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FDA 510(k)

URINARY/CSF PROTEIN

K-Number: K913615 · 1991-09-13

ApplicantBoehringer Mannheim Corp.
Decision Date1991-09-13
Product CodeJGQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URINARY/CSF PROTEIN 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 1991-09-13 under 510(k) number K913615. The device is classified under product code JGQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINARY/CSF PROTEIN?

URINARY/CSF PROTEIN is a medical device that received FDA 510(k) clearance on 1991-09-13. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K913615.

When did URINARY/CSF PROTEIN receive FDA 510(k) clearance?

URINARY/CSF PROTEIN received FDA 510(k) clearance on 1991-09-13, under 510(k) number K913615.

Who is the listed applicant for URINARY/CSF PROTEIN?

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 URINARY/CSF PROTEIN?

The FDA product code for URINARY/CSF PROTEIN is JGQ.

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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: JGQ)

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.

K131051HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)Hitachi Chemical Diagnostics, Inc.K072638ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801Roche Diagnostics Corp.K071239TOTAL PROTEIN URINE/CSF GEN.3Roche DiagnosticsK981295UPROAbbott LaboratoriesK981682UPROAbbott LaboratoriesK925794TRACE MICROPROTEIN REAGENTTrace America, 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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