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FDA 510(k)

TINA-QUANT(R) IGA

K-Number: K862763 · 1986-09-04

ApplicantBoehringer Mannheim Corp.
Decision Date1986-09-04
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TINA-QUANT(R) IGA 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 1986-09-04 under 510(k) number K862763. The device is classified under product code CZP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TINA-QUANT(R) IGA?

TINA-QUANT(R) IGA is a medical device that received FDA 510(k) clearance on 1986-09-04. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K862763.

When did TINA-QUANT(R) IGA receive FDA 510(k) clearance?

TINA-QUANT(R) IGA received FDA 510(k) clearance on 1986-09-04, under 510(k) number K862763.

Who is the listed applicant for TINA-QUANT(R) IGA?

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 TINA-QUANT(R) IGA?

The FDA product code for TINA-QUANT(R) IGA is CZP.

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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.

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Related Devices (Code: CZP)

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.

K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MHORIBA ABX SASK060130IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENTBeckman Coulter, Inc.K040435ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2Roche Diagnostics Corp.K024038N LATEX IGADade Behring, Inc.K993927WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRADWako Chemicals USA, Inc.K983359IGAAbbott Laboratories

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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