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FDA 510(k)

CHEMSPEX(TM) AMMONIA CONTROL

K-Number: K946143 · 1995-02-03

ApplicantClinical Controls, Inc.
Decision Date1995-02-03
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEMSPEX(TM) AMMONIA CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Controls, Inc.. It received FDA 510(k) clearance on 1995-02-03 under 510(k) number K946143. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEMSPEX(TM) AMMONIA CONTROL?

CHEMSPEX(TM) AMMONIA CONTROL is a medical device that received FDA 510(k) clearance on 1995-02-03. The listed applicant is Clinical Controls, Inc.. The 510(k) number is K946143.

When did CHEMSPEX(TM) AMMONIA CONTROL receive FDA 510(k) clearance?

CHEMSPEX(TM) AMMONIA CONTROL received FDA 510(k) clearance on 1995-02-03, under 510(k) number K946143.

Who is the listed applicant for CHEMSPEX(TM) AMMONIA CONTROL?

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

What is the FDA product code for CHEMSPEX(TM) AMMONIA CONTROL?

The FDA product code for CHEMSPEX(TM) AMMONIA CONTROL is JJX.

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Other records listing Clinical Controls, 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.

K964278WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6K962432LIQUISPEX URINE (MICRO)ALBUMIN CONTROLK955691SERUM VOLATILES CONTROL LEVEL 1 & 2K955690AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3K946265FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3K935598PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2

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Related Devices (Code: JJX)

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.

K170678Beta-CrossLaps CalCheck 5Roche DiagnosticsK162173Elecsys CYFRA 21-1 CalCheck 5Roche DiagnosticsK162514Multichem A1cTechnopath ManufacturingK161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.K161522LIAISON EBV IgM Serum Control SetDiaSorin, 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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