510(k) K952720 ยท JPK Mixture, Hematology Quality Control
AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II
| Applicant | Aalto Scientific, Ltd., Vista CA, US |
| Decision | Substantially Equivalent, Sep 20, 1995 |
| Received | Jun 15, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952720
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2022 | Primus Corporation dba Trinity Biotech A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis Terminated |
JPK | None listed |
| Dec 1, 2022 | Primus Corporation dba Trinity Biotech Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis Terminated |
JPK | None listed |
| Nov 15, 2005 | Tosoh Bioscience, Inc. Tosoh brand Glycohemoglobin A1c Controls I & II,
Catalog Number: 992133;
Product is distributed by TOSOH Bioscience Inc., 347 Oyster Point Blvd. Suite 201, South San Francisco, CA 94080. Terminated |
JPK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.