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FDA 510(k)

CRYPTOSPORIDIUM TEST

K-Number: K980354 · 1998-05-18

ApplicantTechlab, Inc.
Decision Date1998-05-18
Product CodeMHJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CRYPTOSPORIDIUM TEST is the device name listed in this FDA 510(k) record. The listed applicant is Techlab, Inc.. It received FDA 510(k) clearance on 1998-05-18 under 510(k) number K980354. The device is classified under product code MHJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYPTOSPORIDIUM TEST?

CRYPTOSPORIDIUM TEST is a medical device that received FDA 510(k) clearance on 1998-05-18. The listed applicant is Techlab, Inc.. The 510(k) number is K980354.

When did CRYPTOSPORIDIUM TEST receive FDA 510(k) clearance?

CRYPTOSPORIDIUM TEST received FDA 510(k) clearance on 1998-05-18, under 510(k) number K980354.

Who is the listed applicant for CRYPTOSPORIDIUM TEST?

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

What is the FDA product code for CRYPTOSPORIDIUM TEST?

The FDA product code for CRYPTOSPORIDIUM TEST is MHJ.

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Related Devices (Code: MHJ)

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.

K171078TRI-COMBO PARASITE SCREENTechlab, Inc.K121565UNI-GOLD CRYPTOSPORIDIUMTrinity BiotechK051929GIARDIA/CRYPTOSPORIDIUM CHEKTechlab, Inc.K052932CRYPTOSPORIDIUM IITechlab, Inc.K031965XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020Remel, Inc.K031059IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96Ivd Research, 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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