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FDA 510(k)

AMIZYME-SCHISTOSOMA SPP. TEST KIT

K-Number: K842527 · 1984-09-05

ApplicantAmico Lab, Inc.
Decision Date1984-09-05
Product CodeGNH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AMIZYME-SCHISTOSOMA SPP. TEST 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 1984-09-05 under 510(k) number K842527. 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 AMIZYME-SCHISTOSOMA SPP. TEST KIT?

AMIZYME-SCHISTOSOMA SPP. TEST KIT is a medical device that received FDA 510(k) clearance on 1984-09-05. The listed applicant is Amico Lab, Inc.. The 510(k) number is K842527.

When did AMIZYME-SCHISTOSOMA SPP. TEST KIT receive FDA 510(k) clearance?

AMIZYME-SCHISTOSOMA SPP. TEST KIT received FDA 510(k) clearance on 1984-09-05, under 510(k) number K842527.

Who is the listed applicant for AMIZYME-SCHISTOSOMA SPP. TEST 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 AMIZYME-SCHISTOSOMA SPP. TEST KIT?

The FDA product code for AMIZYME-SCHISTOSOMA SPP. TEST 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 KITK842530AMIZYME-EBV TEST KITK842663ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2K842531AMIZYME-HSV TYPES 1 & 2 TEST KITSK842529AMIZYME-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.

K842660ANTI-SCHISTOSOMA SPECIES 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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