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FDA 510(k)

DOCUMENTR AMMONIA/ETHANOLCALIBRATOR

K-Number: K944639 · 1994-11-15

ApplicantCasco Standards
Decision Date1994-11-15
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DOCUMENTR AMMONIA/ETHANOLCALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Casco Standards. It received FDA 510(k) clearance on 1994-11-15 under 510(k) number K944639. 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 DOCUMENTR AMMONIA/ETHANOLCALIBRATOR?

DOCUMENTR AMMONIA/ETHANOLCALIBRATOR is a medical device that received FDA 510(k) clearance on 1994-11-15. The listed applicant is Casco Standards. The 510(k) number is K944639.

When did DOCUMENTR AMMONIA/ETHANOLCALIBRATOR receive FDA 510(k) clearance?

DOCUMENTR AMMONIA/ETHANOLCALIBRATOR received FDA 510(k) clearance on 1994-11-15, under 510(k) number K944639.

Who is the listed applicant for DOCUMENTR AMMONIA/ETHANOLCALIBRATOR?

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 DOCUMENTR AMMONIA/ETHANOLCALIBRATOR?

The FDA product code for DOCUMENTR AMMONIA/ETHANOLCALIBRATOR 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 CONTROLK962629DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATORK961750DOCUMENT CARDIAC ASSAYED CONTROLK962630DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROLK960244DOCUMENT TDM ULTRA ASSAYED 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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