510(k) K882799 ยท KHE Reagent, Occult Blood
HELENA COLOCARE
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Sep 30, 1988 |
| Received | Jul 6, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882799
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2018 | Helena Laboratories, Corp. ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX. Open, Classified |
KHE | None listed |
| Aug 8, 2018 | Helena Laboratories, Corp. ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX. Open, Classified |
KHE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.