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FDA 510(k)

CHLAMYDIATROL AG

K-Number: K972129 · 1997-08-12

ApplicantBlackhawk Biosystems, Inc.
Decision Date1997-08-12
Product CodeMJZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHLAMYDIATROL AG is the device name listed in this FDA 510(k) record. The listed applicant is Blackhawk Biosystems, Inc.. It received FDA 510(k) clearance on 1997-08-12 under 510(k) number K972129. The device is classified under product code MJZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHLAMYDIATROL AG?

CHLAMYDIATROL AG is a medical device that received FDA 510(k) clearance on 1997-08-12. The listed applicant is Blackhawk Biosystems, Inc.. The 510(k) number is K972129.

When did CHLAMYDIATROL AG receive FDA 510(k) clearance?

CHLAMYDIATROL AG received FDA 510(k) clearance on 1997-08-12, under 510(k) number K972129.

Who is the listed applicant for CHLAMYDIATROL AG?

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

What is the FDA product code for CHLAMYDIATROL AG?

The FDA product code for CHLAMYDIATROL AG is MJZ.

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Other records listing Blackhawk Biosystems, 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.

K974613VIROTROL IIIK954298VIROTROL IVK942295VIROTROL TORCH

Related Devices (Code: MJZ)

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.

K083744BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010Binax, Inc.K972182ABBOTT STREP A CONTROLSAbbott Diagnostics

Official Source

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

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