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FDA 510(k)

REFLOTRON(R) AST (GOT)

K-Number: K870246 · 1987-02-18

ApplicantBoehringer Mannheim Corp.
Decision Date1987-02-18
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REFLOTRON(R) AST (GOT) 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 1987-02-18 under 510(k) number K870246. The device is classified under product code CIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFLOTRON(R) AST (GOT)?

REFLOTRON(R) AST (GOT) is a medical device that received FDA 510(k) clearance on 1987-02-18. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K870246.

When did REFLOTRON(R) AST (GOT) receive FDA 510(k) clearance?

REFLOTRON(R) AST (GOT) received FDA 510(k) clearance on 1987-02-18, under 510(k) number K870246.

Who is the listed applicant for REFLOTRON(R) AST (GOT)?

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 REFLOTRON(R) AST (GOT)?

The FDA product code for REFLOTRON(R) AST (GOT) is CIT.

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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: CIT)

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.

K093883AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-Seppim S.A.S.K080485ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FSDiasys Diagnostics Systems GmbHK071525ACTIVATED ASPARTATE AMINOTRANSFERASEAbbott LaboratoriesK071580AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROLThermofisher Scientific OYK071211COBAS C 111 ANALYZERRoche DiagnosticsK060318HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERHoriba Abx

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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