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FDA 510(k)

REFLAB SYSTEM PACK LIQUID CO2 REAGENT

K-Number: K926320 · 1993-02-03

ApplicantMedical Analysis Systems, Inc.
Decision Date1993-02-03
Product CodeCHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REFLAB SYSTEM PACK LIQUID CO2 REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 1993-02-03 under 510(k) number K926320. The device is classified under product code CHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFLAB SYSTEM PACK LIQUID CO2 REAGENT?

REFLAB SYSTEM PACK LIQUID CO2 REAGENT is a medical device that received FDA 510(k) clearance on 1993-02-03. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K926320.

When did REFLAB SYSTEM PACK LIQUID CO2 REAGENT receive FDA 510(k) clearance?

REFLAB SYSTEM PACK LIQUID CO2 REAGENT received FDA 510(k) clearance on 1993-02-03, under 510(k) number K926320.

Who is the listed applicant for REFLAB SYSTEM PACK LIQUID CO2 REAGENT?

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

What is the FDA product code for REFLAB SYSTEM PACK LIQUID CO2 REAGENT?

The FDA product code for REFLAB SYSTEM PACK LIQUID CO2 REAGENT is CHS.

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Other records listing Medical Analysis Systems, 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.

K042717MAS, DADE AND LIQUID ASSAYED DIABETES CONTROLK041194ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND HK040880MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3K032826MAS PAR TDMK032335MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TLK031890MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL

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Related Devices (Code: CHS)

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.

K911838ROCHE REAGENT FOR C02Roche Diagnostic Systems, Inc.K860660AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTSAmresco, Inc.K841080TECHNICON RA-1000 SYS CO2Technicon Instruments Corp.K811257CORNING 965 CARBON DIOXIDE ANALYZERCorning Medical & ScientificK802376KODAK EKTA-CHEM CLINICAL CHEM. SLIDESEastman Kodak Company

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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