510(k) K993787 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
APPRAISE-CARDIO SAMPLE COLLECTION KIT
| Applicant | Osborn Group, Inc., Olathe KS, US |
| Decision | Substantially Equivalent, Apr 14, 2000 |
| Received | Nov 9, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993787
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Heritage Labs International LLC Bravo Wellness Kit, Product A1778, each kit packed in a bag or envelope. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies, a Terminated |
JKA | None listed |
| Jan 11, 2012 | Heritage Labs International LLC AGLH - Lung Health Study, Specimen Collection & Return Kit, Phlebotomy & Urine Kit, Product A2351, 10 kits/shipping carton, each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 507 Terminated |
JKA | None listed |
| Jan 11, 2012 | Heritage Labs International LLC Biometric Combo Test Kit, Product K8500, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and Terminated |
JKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.