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FDA 510(k)

BICARBONATE; SYSTEM PACK REAGENTS

K-Number: K891991 · 1989-06-09

ApplicantBoehringer Mannheim Corp.
Decision Date1989-06-09
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BICARBONATE; SYSTEM PACK REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1989-06-09 under 510(k) number K891991. The device is classified under product code KHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BICARBONATE; SYSTEM PACK REAGENTS?

BICARBONATE; SYSTEM PACK REAGENTS is a medical device that received FDA 510(k) clearance on 1989-06-09. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K891991.

When did BICARBONATE; SYSTEM PACK REAGENTS receive FDA 510(k) clearance?

BICARBONATE; SYSTEM PACK REAGENTS received FDA 510(k) clearance on 1989-06-09, under 510(k) number K891991.

Who is the listed applicant for BICARBONATE; SYSTEM PACK REAGENTS?

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

What is the FDA product code for BICARBONATE; SYSTEM PACK REAGENTS?

The FDA product code for BICARBONATE; SYSTEM PACK REAGENTS is KHS.

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Other records listing Boehringer Mannheim 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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Related Devices (Code: KHS)

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.

K170200Carbon Dioxide Reagent SetTeco Diagnostics, Inc.K152085Liquid CO2-2 (LCO2-2)Randox Laboratories, Ltd.K131546AU BICARBONATE REAGENTBeckman Coulter Ireland, Inc.K123953ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K120765VITROS CHEMISTRY PRODUCTS ECO2 SLIDESOrtho-Clinical Diagnostics, Inc.K113435ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann

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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