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FDA 510(k)

TINA-QUANT(R) IGG

K-Number: K862764 · 1986-09-03

ApplicantBoehringer Mannheim Corp.
Decision Date1986-09-03
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TINA-QUANT(R) IGG 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 1986-09-03 under 510(k) number K862764. The device is classified under product code DEW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TINA-QUANT(R) IGG?

TINA-QUANT(R) IGG is a medical device that received FDA 510(k) clearance on 1986-09-03. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K862764.

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

TINA-QUANT(R) IGG received FDA 510(k) clearance on 1986-09-03, under 510(k) number K862764.

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

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) IGG?

The FDA product code for TINA-QUANT(R) IGG is DEW.

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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: DEW)

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.

K050113TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K040434ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K010617SPIFE IFE CALIBRATOR AND CONTROL KITHelena LaboratoriesK993928WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARDWako Chemicals USA, Inc.K993281K-ASSAY IGGKamiya Biomedical Co.K983221IGGAbbott 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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