510(k) K955286 ยท CGA Glucose Oxidase, Glucose
EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, May 17, 1996 |
| Received | Nov 16, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955286
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2025 | Ortho-Clinical Diagnostics, Inc. Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests. Open, Classified |
KHP | None listed |
| Sep 12, 2025 | Ortho-Clinical Diagnostics, Inc. VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests. Open, Classified |
KHP | None listed |
| Jun 17, 2019 | Ortho-Clinical Diagnostics VITROS Chemistry Products GLU Slides-Product Code:1707801.
IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid Terminated |
CGA | None listed |
| Aug 11, 2016 | Ortho-Clinical Diagnostics VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572, Rx ONLY, IVD ---
For in vitro diagnostic use only. VITROS C Terminated |
CGA | None listed |
| Aug 11, 2016 | Ortho-Clinical Diagnostics VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90 slides per sales unit), Unique Device Identifier Nos. 10758750004911 and 10758750004454, R Terminated |
KHP | None listed |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products GLU Slides packaged as 300 slides/pack catalog number 1707801
VITROS GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine and cerebrospinal f Terminated |
CGA | None listed |
| Sep 11, 2003 | Ortho-Clinical Diagnostics Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each containing 60 slides for a total of 300 tests per box *** REF 170 7801 *** Ortho-Clinical Diagnostics Inc., 100 Indigo Creek Drive, R Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.