FDA 510(k)

COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI

K-Number: K942647 · 1995-07-12

Decision Date1995-07-12

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI is the device name listed in this FDA 510(k) record. The listed applicant is Scantibodies Laboratory, Inc.. It received FDA 510(k) clearance on 1995-07-12 under 510(k) number K942647. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI?

COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI is a medical device that received FDA 510(k) clearance on 1995-07-12. The listed applicant is Scantibodies Laboratory, Inc.. The 510(k) number is K942647.

When did COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI receive FDA 510(k) clearance?

COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI received FDA 510(k) clearance on 1995-07-12, under 510(k) number K942647.

Who is the listed applicant for COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI?

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

What is the FDA product code for COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI?

The FDA product code for COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI is JJY.

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Other records listing Scantibodies Laboratory, Inc. as applicant

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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.