Company
Biocare Medical, LLC
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2024 | Biocare Medical, LLC intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB
Buffer, Catalog Number: IPBF5009G20;
ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPR Open, Classified |
PPM | None listed |
| Feb 25, 2021 | Biocare Medical, LLC BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1 Terminated |
KPA | None listed |
| Oct 10, 2019 | Biocare Medical, LLC 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H Terminated |
NJT | None listed |
| Apr 24, 2018 | Biocare Medical, LLC Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) detection system. Catalog numbers FR805-5L and FR805S Terminated |
NJT | None listed |
| Mar 15, 2018 | Biocare Medical, LLC URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM373DSAA, Package Type: Bottle, and b) CK20, Catalog #: PM062A Terminated |
NJT | None listed |
| Mar 31, 2016 | Biocare Medical, LLC Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit;
Catalog number M4U534L;
For In Vitro Use
Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conju Terminated |
NJT | None listed |
| Nov 9, 2015 | Biocare Medical, LLC Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted and ready to use. They are the same product with the same inte Terminated |
NJT | None listed |
| May 26, 2015 | Biocare Medical, LLC D2-40 (Lymphatic Marker); For In Vitro Diagnostic;
Catalog number: PM266AA
Product Usage:
In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative Terminated |
NJT | None listed |
| Apr 27, 2015 | Biocare Medical, LLC CD99
Catalog number PM008 AA;
For In Vitro Diagnostic Use.
Product Usage:
Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology metho Terminated |
NJT | None listed |
| Jan 13, 2015 | Biocare Medical Llc MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA;
Product Usage: For In Vitro Diagnostic Use. This antibody may be used as a tool for the identification and the sub classification of ly Terminated |
NJT | None listed |
| Apr 10, 2012 | Biocare Medical Llc BioCare Medical Vina Green Chromogen Kit; 25 mL, 100ml IVD. Kits include: Vina Green Chromogen 1. 0 mL; Vina Green Buffer, 25 mL and Vina Green Dropper Bottle. BioCare Medical, Concord, CA 94520.
V Terminated |
NJT | None listed |