Sclavo, Inc.: FDA clearances and approvals
Sclavo, Inc. has 82 FDA 510(k) clearances (first 1977, latest 1992), across 63 product codes in 5 review panels. Median 510(k) review time: 48 days.
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 |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 4 | 4 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 3 | 3 |
| DIH | Colorimetry, Cholinesterase | 3 | 3 |
| JFJ | Catalytic Methods, Amylase | 3 | 3 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 | 2 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 2 | 2 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 | 2 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 | 2 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 2 | 2 |
| CIC | Cresolphthalein Complexone, Calcium | 2 | 2 |
Plus 53 more product codes.
Review panels
- Clinical Chemistry (61)
- Clinical Toxicology (10)
- Microbiology (5)
- Immunology (4)
- Hematology (2)
Most recent Sclavo, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K914789 | ELISA CMV IGM | LKQ | 1992-03-04 | 133 |
| K914852 | ELISA TOXO IGM | LGD | 1992-01-23 | 87 |
| K914420 | ELISA RUBELLA IGM | LFX | 1991-12-27 | 85 |
| K895943 | NORMAL AND ABNORMAL CONTROL SERA | JJY | 1989-12-27 | 77 |
| K895822 | TOTAL BILIRUBIN L.F. | CIG | 1989-11-14 | 46 |
| K895847 | CREATININE 340 (ENZYMATIC) | CGX | 1989-10-30 | 27 |
| K880199 | CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE | DIH | 1989-01-27 | 380 |
| K880049 | CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE | DIH | 1989-01-27 | 387 |
| K873496 | ATYPICAL CHOLINESTERASE | DIH | 1989-01-27 | 528 |
| K884035 | SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER | JJE | 1988-12-29 | 97 |
72 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sclavo, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Sclavo, Inc. have?
Sclavo, Inc. has 82 FDA 510(k) clearances (first 1977, latest 1992), across 63 product codes in 5 review panels.
How long does FDA take to clear Sclavo, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sclavo, Inc.'s cleared 510(k)s is 48 days.
What devices does Sclavo, Inc. make?
Its most frequent FDA product codes are CHH (Enzymatic Esterase--Oxidase, Cholesterol, 4); CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes, 3); DIH (Colorimetry, Cholinesterase, 3).
Has Sclavo, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sclavo, Inc. Related entities may recall under other names.
Next steps
- See all 82 Sclavo, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CHH, Sclavo, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.