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FDA 510(k)

CRYPTO-LEX SYSTEM

K-Number: K930418 · 1994-02-17

ApplicantTrinity Laboratories, Inc.
Decision Date1994-02-17
Product CodeGMD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CRYPTO-LEX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Laboratories, Inc.. It received FDA 510(k) clearance on 1994-02-17 under 510(k) number K930418. The device is classified under product code GMD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYPTO-LEX SYSTEM?

CRYPTO-LEX SYSTEM is a medical device that received FDA 510(k) clearance on 1994-02-17. The listed applicant is Trinity Laboratories, Inc.. The 510(k) number is K930418.

When did CRYPTO-LEX SYSTEM receive FDA 510(k) clearance?

CRYPTO-LEX SYSTEM received FDA 510(k) clearance on 1994-02-17, under 510(k) number K930418.

Who is the listed applicant for CRYPTO-LEX SYSTEM?

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

What is the FDA product code for CRYPTO-LEX SYSTEM?

The FDA product code for CRYPTO-LEX SYSTEM is GMD.

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Other records listing Trinity Laboratories, 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.

K981441HEART CATH TRAY, STERILE, DISPOSABLEK974238DENTAL TRAY, STERILE, DISPOSABLEK974286CIRCUMCISION TRAY, CAT. NO. 70340K972160CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TESTK970722EYE TRAYK965201O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE

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Related Devices (Code: GMD)

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.

K112422CRAG LATERAL FLOW ASSAY (LFA)Immuno-Mycologics, Inc.K102286CRAG LATERAL FLOW ASSAY (CRAG LFA)Immuno-Mycologics, Inc.K933997PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAYAlexon Biomedical, Inc.K894845(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASEMeridian Diagnostics, Inc.K812188CRYPTOCOCCAL ANTIGEN LATEX AGGLUTIAmerican Scientific ProductsK810510YA-CRYPTO ANTIBODY TUBE AGGLUTINATIONImmuno-Mycologics, 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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