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FDA 510(k)

CREATININE FOR CONTINUOUS FLOW INSTRUMENTS

K-Number: K881400 · 1988-04-28

ApplicantCatachem, Inc.
Decision Date1988-04-28
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATININE FOR CONTINUOUS FLOW INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Catachem, Inc.. It received FDA 510(k) clearance on 1988-04-28 under 510(k) number K881400. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREATININE FOR CONTINUOUS FLOW INSTRUMENTS?

CREATININE FOR CONTINUOUS FLOW INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1988-04-28. The listed applicant is Catachem, Inc.. The 510(k) number is K881400.

When did CREATININE FOR CONTINUOUS FLOW INSTRUMENTS receive FDA 510(k) clearance?

CREATININE FOR CONTINUOUS FLOW INSTRUMENTS received FDA 510(k) clearance on 1988-04-28, under 510(k) number K881400.

Who is the listed applicant for CREATININE FOR CONTINUOUS FLOW INSTRUMENTS?

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 CREATININE FOR CONTINUOUS FLOW INSTRUMENTS?

The FDA product code for CREATININE FOR CONTINUOUS FLOW INSTRUMENTS is CGX.

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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 ANALYZERK932871UIBC FOR DISCREET RANDOM ACCESS ANALYZERK903341MAGNESIUMK902326AMYLASE FOR MANUAL/AUTOMATED APPLICATIONSK902877TOTAL IRON FOR MANUAL/AUTOMATED

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Related Devices (Code: CGX)

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.

K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian HealthK242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc.K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK210452Creatinine2Abbott Ireland Diagnostics DivisionK161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare Diagnostics, 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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