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FDA 510(k)

KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA

K-Number: K922736 · 1992-07-10

ApplicantEastman Kodak Company
Decision Date1992-07-10
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA is the device name listed in this FDA 510(k) record. The listed applicant is Eastman Kodak Company. It received FDA 510(k) clearance on 1992-07-10 under 510(k) number K922736. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA?

KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA is a medical device that received FDA 510(k) clearance on 1992-07-10. The listed applicant is Eastman Kodak Company. The 510(k) number is K922736.

When did KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA receive FDA 510(k) clearance?

KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA received FDA 510(k) clearance on 1992-07-10, under 510(k) number K922736.

Who is the listed applicant for KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA?

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

What is the FDA product code for KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA?

The FDA product code for KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA is JLW.

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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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