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FDA 510(k)

PTT-LT TEST KIT

K-Number: K941210 · 1995-03-21

ApplicantAmerican Bioproducts Co.
Decision Date1995-03-21
Product CodeGGW
Advisory CommitteeHE
DecisionUnknown

Device Summary

PTT-LT 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 1995-03-21 under 510(k) number K941210. The device is classified under product code GGW. It was reviewed by the HE advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the PTT-LT TEST KIT?

PTT-LT TEST KIT is a medical device that received FDA 510(k) clearance on 1995-03-21. The listed applicant is American Bioproducts Co.. The 510(k) number is K941210.

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

PTT-LT TEST KIT received FDA 510(k) clearance on 1995-03-21, under 510(k) number K941210.

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

The FDA product code for PTT-LT TEST KIT is 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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