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FDA 510(k)

BAYER SPECIAL CHEMISTRY CONTROLS

K-Number: K033379 · 2003-12-19

ApplicantBayer Diagnostics Corp.
Decision Date2003-12-19
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BAYER SPECIAL CHEMISTRY CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Diagnostics Corp.. It received FDA 510(k) clearance on 2003-12-19 under 510(k) number K033379. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAYER SPECIAL CHEMISTRY CONTROLS?

BAYER SPECIAL CHEMISTRY CONTROLS is a medical device that received FDA 510(k) clearance on 2003-12-19. The listed applicant is Bayer Diagnostics Corp.. The 510(k) number is K033379.

When did BAYER SPECIAL CHEMISTRY CONTROLS receive FDA 510(k) clearance?

BAYER SPECIAL CHEMISTRY CONTROLS received FDA 510(k) clearance on 2003-12-19, under 510(k) number K033379.

Who is the listed applicant for BAYER SPECIAL CHEMISTRY CONTROLS?

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

What is the FDA product code for BAYER SPECIAL CHEMISTRY CONTROLS?

The FDA product code for BAYER SPECIAL CHEMISTRY CONTROLS is JJY.

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Other records listing Bayer Diagnostics Corp. 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.

K033380BAYER SPECIAL CHEMISTRY CALIBRATORSK033007BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEMK031857ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAYK022096URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMK030452BAYER LIGAND PLUS 1, 2, 3 CONTROLSK023840ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650

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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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