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FDA 510(k)

SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA)

K-Number: K871811 · 1987-05-26

ApplicantBoehringer Mannheim Corp.
Decision Date1987-05-26
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA) 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 1987-05-26 under 510(k) number K871811. The device is classified under product code CIC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA)?

SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA) is a medical device that received FDA 510(k) clearance on 1987-05-26. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K871811.

When did SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA) receive FDA 510(k) clearance?

SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA) received FDA 510(k) clearance on 1987-05-26, under 510(k) number K871811.

Who is the listed applicant for SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA)?

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 SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA)?

The FDA product code for SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA) is CIC.

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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: CIC)

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.

K130870HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)Hitachi Chemical Diagnostics, Inc.K083339DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)Siemens Healthcare Diagnostics, Inc.K070249ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/HHoriba AbxK053401SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTSArkray, Inc.K050077SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTSArkray, Inc.K041009RAICHEM CALCIUM (OCPC) LIQUID REAGENTHemagen 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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