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FDA 510(k)

DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR

K-Number: K962629 · 1996-09-13

ApplicantCasco Standards
Decision Date1996-09-13
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Casco Standards. It received FDA 510(k) clearance on 1996-09-13 under 510(k) number K962629. 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?

DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR is a medical device that received FDA 510(k) clearance on 1996-09-13. The listed applicant is Casco Standards. The 510(k) number is K962629.

When did DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR receive FDA 510(k) clearance?

DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR received FDA 510(k) clearance on 1996-09-13, under 510(k) number K962629.

Who is the listed applicant for DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR?

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?

The FDA product code for DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR is JIX.

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Other records listing Casco Standards 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.

K981436DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109K972904DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROLK962630DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROLK961750DOCUMENT CARDIAC ASSAYED CONTROLK960244DOCUMENT TDM ULTRA ASSAYED CONTROLK955155DOCUMENT TDM ULTRA UNASSAYED CONTROL

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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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