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FDA 510(k)

PTT-LA TEST KIT

K-Number: K921684 · 1992-06-09

ApplicantAmerican Bioproducts Co.
Decision Date1992-06-09
Product CodeGGW
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PTT-LA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Bioproducts Co.. It received FDA 510(k) clearance on 1992-06-09 under 510(k) number K921684. The device is classified under product code GGW. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTT-LA TEST KIT?

PTT-LA TEST KIT is a medical device that received FDA 510(k) clearance on 1992-06-09. The listed applicant is American Bioproducts Co.. The 510(k) number is K921684.

When did PTT-LA TEST KIT receive FDA 510(k) clearance?

PTT-LA TEST KIT received FDA 510(k) clearance on 1992-06-09, under 510(k) number K921684.

Who is the listed applicant for PTT-LA TEST KIT?

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

What is the FDA product code for PTT-LA TEST KIT?

The FDA product code for PTT-LA TEST KIT is GGW.

Other records listing American Bioproducts Co. 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.

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Related Devices (Code: GGW)

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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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