Sterling Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 41 510(k) clearances under the applicant name “Sterling Diagnostics, Inc.” (first 1985, latest 1993), across 39 product codes in 3 review panels. Median 510(k) review time under this name: 28 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 2 | 2 |
| CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | 1 |
| CDL | Berthelot Indophenol, Urea Nitrogen | 1 | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 | 1 |
| CEI | Uranyl Acetate/Zinc Acetate, Sodium | 1 | 1 |
| CEJ | Tetraphenyl Borate, Colorimetry, Potassium | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFG | Oil Emulsion/Thymolphthalein (Titrimetric), Lipase | 1 | 1 |
Plus 29 more product codes.
Review panels
- Clinical Chemistry (37)
- Hematology (2)
- Clinical Toxicology (2)
Most recent Sterling Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921412 | MICROPROTEIN REAGENT SET | CEK | 1993-01-21 | 303 |
| K914609 | TRIGLYCERIDES REAGENT SET | CDT | 1991-11-07 | 21 |
| K914039 | SODIUM REAGENT SET | CEI | 1991-10-31 | 51 |
| K914040 | PHOSPHOLIPID REAGENT SET | JNT | 1991-10-30 | 50 |
| K862255 | LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) | CFJ | 1986-07-29 | 46 |
| K861962 | VANILMANDELIC ACID (VMA) REAGENT SET | CDF | 1986-07-07 | 48 |
| K862256 | ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET | CJE | 1986-07-01 | 18 |
| K862210 | UREA NITROGEN (GLDH) REAGENT SET (UV) | CDQ | 1986-07-01 | 21 |
| K862209 | ALT (SGPT) REAGENT SET (UV RATE) | CKA | 1986-06-25 | 15 |
| K861855 | HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET | JKF | 1986-06-16 | 33 |
31 earlier clearances. See the full list in Caduvo.
Recalls
9 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2016-07-20.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Sterling Diagnostics, Inc. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sterling Medivations, Inc. (27 510(k)s)
- Sterling Biochemical, Inc. (15 510(k)s)
- Sterling Drug, Inc. (9 510(k)s)
- Sterling Diagnostic Imaging, Inc. (7 510(k)s)
- Sterling Medical Devices, Inc. (2 510(k)s)
- Sterling Medical, Inc. (1 510(k)s)
- Sterling Multi-Products, Inc. (1 510(k)s)
- Sterling U.S.A., Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sterling Diagnostics, Inc.?
FDA lists 41 510(k) clearances under the applicant name “Sterling Diagnostics, Inc.” (first 1985, latest 1993), across 39 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sterling Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sterling Diagnostics, Inc. is 28 days.
Which FDA product codes appear under Sterling Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 2); CEK (Biuret (Colorimetric), Total Protein, 2); CDF (Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin, 1).
Next steps
- See all 41 Sterling Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDT, Sterling Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.