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FDA 510(k)

IN VITRO DIAGNOSTIC REAGENTS

K-Number: K770506 · 1977-05-06

ApplicantNorwood Scientific Associates, Inc.
Decision Date1977-05-06
Product CodeJJC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IN VITRO DIAGNOSTIC REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Norwood Scientific Associates, Inc.. It received FDA 510(k) clearance on 1977-05-06 under 510(k) number K770506. The device is classified under product code JJC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IN VITRO DIAGNOSTIC REAGENTS?

IN VITRO DIAGNOSTIC REAGENTS is a medical device that received FDA 510(k) clearance on 1977-05-06. The listed applicant is Norwood Scientific Associates, Inc.. The 510(k) number is K770506.

When did IN VITRO DIAGNOSTIC REAGENTS receive FDA 510(k) clearance?

IN VITRO DIAGNOSTIC REAGENTS received FDA 510(k) clearance on 1977-05-06, under 510(k) number K770506.

Who is the listed applicant for IN VITRO DIAGNOSTIC REAGENTS?

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

What is the FDA product code for IN VITRO DIAGNOSTIC REAGENTS?

The FDA product code for IN VITRO DIAGNOSTIC REAGENTS is JJC.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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