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FDA 510(k)

SINGLE VIAL 10 SGPT-TRIS

K-Number: K780636 · 1978-05-18

ApplicantBoehringer Mannheim Corp.
Decision Date1978-05-18
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SINGLE VIAL 10 SGPT-TRIS is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1978-05-18 under 510(k) number K780636. The device is classified under product code CKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE VIAL 10 SGPT-TRIS?

SINGLE VIAL 10 SGPT-TRIS is a medical device that received FDA 510(k) clearance on 1978-05-18. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K780636.

When did SINGLE VIAL 10 SGPT-TRIS receive FDA 510(k) clearance?

SINGLE VIAL 10 SGPT-TRIS received FDA 510(k) clearance on 1978-05-18, under 510(k) number K780636.

Who is the listed applicant for SINGLE VIAL 10 SGPT-TRIS?

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

What is the FDA product code for SINGLE VIAL 10 SGPT-TRIS?

The FDA product code for SINGLE VIAL 10 SGPT-TRIS is CKA.

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Related Devices (Code: CKA)

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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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