Clark Laboratories, Inc.
Clark Laboratories, Inc. holds FDA 510(k) medical device clearances, first cleared 1992, most recent 1998, with 2 FDA device recalls on record.
Top product codes for Clark Laboratories, Inc.
FDA recalls by Clark Laboratories, Inc.
- Z-0382-2022 — Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440
- Z-1503-2021 — Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Clark Laboratories, Inc.
- K980596 — VCA IGM ELISA TEST SYSTEM
- K980912 — VCA IGG ELISA TEST SYSTEM
- K980598 — EBNA-1 IGM ELISA TEST SYSTEM
- K973123 — EA-D IGG ELISA TEST SYSTEM
- K931543 — ENCORE ENA COMBINED EIA
- K925826 — ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA
- K923537 — ENCORE DS-DNA
- K921572 — ENCORE SM
- K921870 — ENCORE SM/RNP
- K922340 — ENCORE SS-B
- K922157 — ENCORE SS-A
- K924056 — ENCORE RHEUMATOID FACTOR EIA
- K921573 — RUBELLA IGM
- K920150 — ENCORE SCL-70
Data sourced from openFDA. This site is unofficial and independent of the FDA.