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FDA 510(k)

UIBC FOR DISCREET RANDOM ACCESS ANALYZER

K-Number: K932871 · 1993-09-08

ApplicantCatachem, Inc.
Decision Date1993-09-08
Product CodeCFM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UIBC FOR DISCREET RANDOM ACCESS ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Catachem, Inc.. It received FDA 510(k) clearance on 1993-09-08 under 510(k) number K932871. The device is classified under product code CFM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UIBC FOR DISCREET RANDOM ACCESS ANALYZER?

UIBC FOR DISCREET RANDOM ACCESS ANALYZER is a medical device that received FDA 510(k) clearance on 1993-09-08. The listed applicant is Catachem, Inc.. The 510(k) number is K932871.

When did UIBC FOR DISCREET RANDOM ACCESS ANALYZER receive FDA 510(k) clearance?

UIBC FOR DISCREET RANDOM ACCESS ANALYZER received FDA 510(k) clearance on 1993-09-08, under 510(k) number K932871.

Who is the listed applicant for UIBC FOR DISCREET RANDOM ACCESS ANALYZER?

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

What is the FDA product code for UIBC FOR DISCREET RANDOM ACCESS ANALYZER?

The FDA product code for UIBC FOR DISCREET RANDOM ACCESS ANALYZER is CFM.

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Other records listing Catachem, 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.

K062503CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KITK945408340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZERK903341MAGNESIUMK902326AMYLASE FOR MANUAL/AUTOMATED APPLICATIONSK902877TOTAL IRON FOR MANUAL/AUTOMATEDK895748BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS

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Related Devices (Code: CFM)

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.

K984119WAKO L-TYPE FE, WAKO L-TYPE CALIBRATORWako Chemicals USA, Inc.K981581IRONAbbott LaboratoriesK913705ABBOTT QLUICKSTART IRON TEST, ITEM #5A29Em Diagnostic Systems, Inc.K912912SYNERMED SERUM IRON-600 REAGENT KITSynermed, Inc.K902918SYNERMED SERUM IRON REAGENT KITSynermed, Inc.K895047CLINISTAT POTASSIUM REAGENT TESTHeraeus Kulzer, 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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