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FDA 510(k)

STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED

K-Number: K924074 · 1992-10-26

ApplicantBaxter Diagnostics, Inc.
Decision Date1992-10-26
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-10-26 under 510(k) number K924074. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED?

STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED is a medical device that received FDA 510(k) clearance on 1992-10-26. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K924074.

When did STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED receive FDA 510(k) clearance?

STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED received FDA 510(k) clearance on 1992-10-26, under 510(k) number K924074.

Who is the listed applicant for STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED?

The FDA 510(k) record lists Baxter Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED?

The FDA product code for STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED is CDD.

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Other records listing Baxter Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K934458DRIED GRAM-POSITIVE MIC/COMBO PANELSK950817DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCIK935704DRIED GRAM-NEGATIVE MIC//COMBO PANELSK950570STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAYK945235DRIED GRAM-POSITIVE MIC/COMBO PANELSK941030DRIED GRAM-NEGATIVE CEFPODOXIME

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Related Devices (Code: CDD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233541ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.K223289Access Vitamin B12Beckman Coulter, Inc.K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12Beckman Coulter Biomedical GmbHK192064LIAISON Vitamin B12DiaSorin, Inc.K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics, Ltd.K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetDiazyme Laboratories

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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