Clark Laboratories, Inc.
FDA Regulatory Profile
Clark Laboratories, Inc. appears in FDA public data with 2 recalls, 14 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0382-2022, Class II) was initiated on October 11, 2021. Its most recent 510(k) clearance was granted on July 22, 1998.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 14
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0382-2022 | Class II | Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or c | October 11, 2021 |
| Z-1503-2021 | Class II | Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualit | March 17, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K980596 | VCA IGM ELISA TEST SYSTEM | July 22, 1998 |
| K980912 | VCA IGG ELISA TEST SYSTEM | July 22, 1998 |
| K980598 | EBNA-1 IGM ELISA TEST SYSTEM | May 1, 1998 |
| K973123 | EA-D IGG ELISA TEST SYSTEM | March 26, 1998 |
| K931543 | ENCORE ENA COMBINED EIA | September 8, 1993 |
| K925826 | ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA | January 26, 1993 |
| K923537 | ENCORE DS-DNA | December 23, 1992 |
| K921870 | ENCORE SM/RNP | December 1, 1992 |
| K921572 | ENCORE SM | December 1, 1992 |
| K922340 | ENCORE SS-B | October 16, 1992 |
| K922157 | ENCORE SS-A | October 13, 1992 |
| K924056 | ENCORE RHEUMATOID FACTOR EIA | September 25, 1992 |
| K921573 | RUBELLA IGM | August 27, 1992 |
| K920150 | ENCORE SCL-70 | March 18, 1992 |