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FDA 510(k)

DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109

K-Number: K981436 · 1998-04-24

ApplicantCasco Standards
Decision Date1998-04-24
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 is the device name listed in this FDA 510(k) record. The listed applicant is Casco Standards. It received FDA 510(k) clearance on 1998-04-24 under 510(k) number K981436. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109?

DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 is a medical device that received FDA 510(k) clearance on 1998-04-24. The listed applicant is Casco Standards. The 510(k) number is K981436.

When did DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 receive FDA 510(k) clearance?

DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 received FDA 510(k) clearance on 1998-04-24, under 510(k) number K981436.

Who is the listed applicant for DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109?

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

What is the FDA product code for DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109?

The FDA product code for DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 is JIX.

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Other records listing Casco Standards as applicant

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Related Devices (Code: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens 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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