Earl-Clay Laboratories, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Earl-Clay Laboratories, Inc.” (first 1984, latest 1986), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 39 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 |
|---|---|---|---|
| KIR | Cells, Animal And Human, Cultured | 17 | 17 |
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 3 | 3 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 1 | 1 |
Review panels
Most recent Earl-Clay Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861585 | ULTRACLONE 01-2300 CELL LINE | KIR | 1986-05-13 | 14 |
| K861569 | ULTRACLONE 01-700 CELL LINE | KIR | 1986-05-05 | 7 |
| K854206 | ULTRACLONE 05-100 GUINEA PIG RBC | KPO | 1985-10-31 | 15 |
| K853203 | ULTRACLONE ECL-01-2200 CELL LINE | KIR | 1985-08-12 | 13 |
| K851545 | ULTRACLONE ECL-01-800 CELL LINE | KIR | 1985-05-10 | 24 |
| K843579 | ULTRACLONE ECL-01-1100 | KIR | 1984-10-31 | 50 |
| K843578 | ULTRACLONE ECL-01-2100 CELL LINE | KIR | 1984-10-31 | 50 |
| K843577 | ULTRAXLONE ECL-01-1000 CELL LINE | KIR | 1984-10-31 | 50 |
| K843864 | ULTRACLONE ECL-01-1400 CELL LINE | KIT | 1984-10-17 | 15 |
| K843863 | ULTRACLONE ECL-01-1300 CELL LINE | KIT | 1984-10-17 | 15 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Earl-Clay Laboratories, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Earl-Clay Laboratories, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Earl-Clay Laboratories, Inc.” (first 1984, latest 1986), across 3 product codes in 2 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 Earl-Clay Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Earl-Clay Laboratories, Inc. is 39 days.
Which FDA product codes appear under Earl-Clay Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are KIR (Cells, Animal And Human, Cultured, 17); KIT (Media And Components, Synthetic Cell And Tissue Culture, 3); KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder), 1).
Next steps
- See all 21 Earl-Clay Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KIR, Earl-Clay Laboratories, 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.