Creative Laboratory Products, Inc.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Creative Laboratory Products, Inc.” (first 1988, latest 1995), across 14 product codes in 3 review panels. Median 510(k) review time under this name: 68 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 8 | 8 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 5 | 5 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 2 | 2 |
| LCP | Assay, Glycosylated Hemoglobin | 2 | 2 |
| GFO | Activated Partial Thromboplastin | 1 | 1 |
| GGC | Control, Plasma, Abnormal | 1 | 1 |
| GIT | Reagent & Control, Partial Thromboplastin Time | 1 | 1 |
| GIZ | Plasma, Control, Normal | 1 | 1 |
| GJS | Test, Time, Prothrombin | 1 | 1 |
| JCM | Control, Hemoglobin, Abnormal | 1 | 1 |
Plus 4 more product codes.
Review panels
- Clinical Chemistry (17)
- Hematology (9)
- General Hospital (1)
Most recent Creative Laboratory Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K950589 | CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL | JJX | 1995-03-20 | 39 |
| K942284 | CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET | JJX | 1994-08-26 | 107 |
| K922995 | LIPID CONTROLS | JJX | 1992-08-12 | 51 |
| K913427 | SICKLE HEMOGLOBIN (HBA/S) CONTROL SET | JCM | 1991-11-19 | 110 |
| K913371 | TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL | JIT | 1991-11-08 | 102 |
| K913585 | LIPASE LINEARITY CONTROL | JJX | 1991-10-21 | 70 |
| K913224 | LIPID LINEARITY CONTROLS | JJY | 1991-09-25 | 68 |
| K913496 | CHOLINESTERASE LINEARITY CONTROL | JJX | 1991-09-11 | 36 |
| K912823 | HIGH DENSITY LIPOPROTEIN CHOLESTEROL | LBR | 1991-08-16 | 51 |
| K912725 | TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL | JJY | 1991-07-30 | 40 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Creative Laboratory Products, Inc..
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.
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.
- Creative Care Systems, Inc. (7 510(k)s)
- Creative Biomedics, Inc. (4 510(k)s)
- Creative Contract (M) Sdn Bhd (3 510(k)s)
- Creative Medical, Inc. (2 510(k)s)
- Creative Medical Designs, Inc. (2 510(k)s)
- Creative Research and Mfg., Inc. (2 510(k)s)
- Creative Balloons GmbH (1 510(k)s)
- Creative Design (1 510(k)s)
- Creative Design Systems, Inc. (1 510(k)s)
- Creative Fitness Developments S.L. (1 510(k)s)
- Creative Images, Inc. (1 510(k)s)
- Creative Instruments (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Creative Laboratory Products, Inc.?
FDA lists 27 510(k) clearances under the applicant name “Creative Laboratory Products, Inc.” (first 1988, latest 1995), across 14 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 Creative Laboratory Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Creative Laboratory Products, Inc. is 68 days.
Which FDA product codes appear under Creative Laboratory Products, Inc.?
The most frequent FDA product codes under this applicant name are JJY (Multi-Analyte Controls, All Kinds (Assayed), 8); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 5); JJT (Enzyme Controls (Assayed And Unassayed), 2).
Next steps
- See all 27 Creative Laboratory Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJY, Creative Laboratory Products, 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.