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FDA 510(k)

LMD CRYPTOSPORIDIUM ANTIGEN DETECTION

K-Number: K955345 · 1996-06-07

ApplicantLmd Laboratories
Decision Date1996-06-07
Product CodeMHJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LMD 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 1996-06-07 under 510(k) number K955345. 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 LMD CRYPTOSPORIDIUM ANTIGEN DETECTION?

LMD CRYPTOSPORIDIUM ANTIGEN DETECTION is a medical device that received FDA 510(k) clearance on 1996-06-07. The listed applicant is Lmd Laboratories. The 510(k) number is K955345.

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

LMD CRYPTOSPORIDIUM ANTIGEN DETECTION received FDA 510(k) clearance on 1996-06-07, under 510(k) number K955345.

Who is the listed applicant for LMD 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 LMD CRYPTOSPORIDIUM ANTIGEN DETECTION?

The FDA product code for LMD 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.

K942705E. COLI 0157 ELISA STOOL ASSAYK944871LMD GIARDIA ANTIGEN DETECTION ASSAYK905598CRYPTOSPORIDIUM ANTIGEN DETECTIONK904613TRICHINELLA 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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