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FDA 510(k)

BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)

K-Number: K992136 · 1999-11-09

ApplicantBayer Corp.
Decision Date1999-11-09
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 1999-11-09 under 510(k) number K992136. The device is classified under product code CIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)?

BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) is a medical device that received FDA 510(k) clearance on 1999-11-09. The listed applicant is Bayer Corp.. The 510(k) number is K992136.

When did BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) receive FDA 510(k) clearance?

BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) received FDA 510(k) clearance on 1999-11-09, under 510(k) number K992136.

Who is the listed applicant for BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)?

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

What is the FDA product code for BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)?

The FDA product code for BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) is CIT.

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Other records listing Bayer Corp. 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.

K024062ASCENSIA BREEZE BLOOD GLUCOSE METERK023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TESTK024017BAYER ADVIA CENTAUR HER-2/NEU ASSAYK024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONALK022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMK023584ASCENSIA DEX 2 DIABETES CARE SYSTEM

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Related Devices (Code: CIT)

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.

K093883AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-Seppim S.A.S.K080485ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FSDiasys Diagnostics Systems GmbHK071525ACTIVATED ASPARTATE AMINOTRANSFERASEAbbott LaboratoriesK071580AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROLThermofisher Scientific OYK071211COBAS C 111 ANALYZERRoche DiagnosticsK060318HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERHoriba Abx

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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