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FDA 510(k)

ANTI-SCHISTOSOMA SPECIES KIT

K-Number: K842660 · 1984-10-30

ApplicantAmico Lab, Inc.
Decision Date1984-10-30
Product CodeGNH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ANTI-SCHISTOSOMA SPECIES KIT is the device name listed in this FDA 510(k) record. The listed applicant is Amico Lab, Inc.. It received FDA 510(k) clearance on 1984-10-30 under 510(k) number K842660. The device is classified under product code GNH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-SCHISTOSOMA SPECIES KIT?

ANTI-SCHISTOSOMA SPECIES KIT is a medical device that received FDA 510(k) clearance on 1984-10-30. The listed applicant is Amico Lab, Inc.. The 510(k) number is K842660.

When did ANTI-SCHISTOSOMA SPECIES KIT receive FDA 510(k) clearance?

ANTI-SCHISTOSOMA SPECIES KIT received FDA 510(k) clearance on 1984-10-30, under 510(k) number K842660.

Who is the listed applicant for ANTI-SCHISTOSOMA SPECIES KIT?

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

What is the FDA product code for ANTI-SCHISTOSOMA SPECIES KIT?

The FDA product code for ANTI-SCHISTOSOMA SPECIES KIT is GNH.

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Other records listing Amico Lab, Inc. as applicant

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.

K842662ANTI-EPSTEIN-BARR VIRUS KITK842531AMIZYME-HSV TYPES 1 & 2 TEST KITSK842663ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2K842530AMIZYME-EBV TEST KITK842529AMIZYME-CMV KITK842661ANTI-CYTOMEGALOVIRUS KIT

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Related Devices (Code: GNH)

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.

K842527AMIZYME-SCHISTOSOMA SPP. TEST KITAmico Lab, Inc.

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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