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FDA 510(k)

CRYPTOSPORIDIUM ANTIGEN DETECTION

K-Number: K905598 · 1991-09-05

ApplicantLmd Laboratories
Decision Date1991-09-05
Product CodeMHJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CRYPTOSPORIDIUM ANTIGEN DETECTION is the device name listed in this FDA 510(k) record. The listed applicant is Lmd Laboratories. It received FDA 510(k) clearance on 1991-09-05 under 510(k) number K905598. 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 ANTIGEN DETECTION?

CRYPTOSPORIDIUM ANTIGEN DETECTION is a medical device that received FDA 510(k) clearance on 1991-09-05. The listed applicant is Lmd Laboratories. The 510(k) number is K905598.

When did CRYPTOSPORIDIUM ANTIGEN DETECTION receive FDA 510(k) clearance?

CRYPTOSPORIDIUM ANTIGEN DETECTION received FDA 510(k) clearance on 1991-09-05, under 510(k) number K905598.

Who is the listed applicant for CRYPTOSPORIDIUM ANTIGEN DETECTION?

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

What is the FDA product code for CRYPTOSPORIDIUM ANTIGEN DETECTION?

The FDA product code for CRYPTOSPORIDIUM ANTIGEN DETECTION is MHJ.

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Other records listing Lmd Laboratories 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.

K955345LMD CRYPTOSPORIDIUM ANTIGEN DETECTIONK942705E. COLI 0157 ELISA STOOL ASSAYK944871LMD GIARDIA ANTIGEN DETECTION ASSAYK904613TRICHINELLA SEROLOGY MICROTITER ELISAK900780CYSTICERCOSIS SEROLOGICAL REAGENTSK890003GIARDIA STOOL ANTIGEN TEST KIT

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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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