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FDA 510(k)

ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS)

K-Number: K891098 · 1989-03-22

ApplicantImmco Diagnostics, Inc.
Decision Date1989-03-22
Product CodeDBL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) is the device name listed in this FDA 510(k) record. The listed applicant is Immco Diagnostics, Inc.. It received FDA 510(k) clearance on 1989-03-22 under 510(k) number K891098. The device is classified under product code DBL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS)?

ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) is a medical device that received FDA 510(k) clearance on 1989-03-22. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K891098.

When did ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) receive FDA 510(k) clearance?

ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) received FDA 510(k) clearance on 1989-03-22, under 510(k) number K891098.

Who is the listed applicant for ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS)?

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

What is the FDA product code for ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS)?

The FDA product code for ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) is DBL.

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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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