FDA 510(k)

DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL

K-Number: K972904 · 1998-02-20

Decision Date1998-02-20

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Casco Standards. It received FDA 510(k) clearance on 1998-02-20 under 510(k) number K972904. 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 DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL?

DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL is a medical device that received FDA 510(k) clearance on 1998-02-20. The listed applicant is Casco Standards. The 510(k) number is K972904.

When did DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL receive FDA 510(k) clearance?

DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL received FDA 510(k) clearance on 1998-02-20, under 510(k) number K972904.

Who is the listed applicant for DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL?

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

What is the FDA product code for DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL?

The FDA product code for DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL is JJY.

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Other records listing Casco Standards as applicant

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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.