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FDA 510(k)

SERAYZER ALT/SGPT REAGENT STRIPS

K-Number: K832791 · 1983-10-14

ApplicantMiles Laboratories, Inc.
Decision Date1983-10-14
Product CodeCKC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERAYZER ALT/SGPT REAGENT STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1983-10-14 under 510(k) number K832791. The device is classified under product code CKC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERAYZER ALT/SGPT REAGENT STRIPS?

SERAYZER ALT/SGPT REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K832791.

When did SERAYZER ALT/SGPT REAGENT STRIPS receive FDA 510(k) clearance?

SERAYZER ALT/SGPT REAGENT STRIPS received FDA 510(k) clearance on 1983-10-14, under 510(k) number K832791.

Who is the listed applicant for SERAYZER ALT/SGPT REAGENT STRIPS?

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

What is the FDA product code for SERAYZER ALT/SGPT REAGENT STRIPS?

The FDA product code for SERAYZER ALT/SGPT REAGENT STRIPS is CKC.

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Other records listing Miles Laboratories, Inc. as applicant

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Related Devices (Code: CKC)

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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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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