Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TINA-QUANT HEMOGLOBIN A1C

K-Number: K934070 · 1994-10-11

ApplicantBoehringer Mannheim Corp.
Decision Date1994-10-11
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TINA-QUANT HEMOGLOBIN A1C 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 1994-10-11 under 510(k) number K934070. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TINA-QUANT HEMOGLOBIN A1C?

TINA-QUANT HEMOGLOBIN A1C is a medical device that received FDA 510(k) clearance on 1994-10-11. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K934070.

When did TINA-QUANT HEMOGLOBIN A1C receive FDA 510(k) clearance?

TINA-QUANT HEMOGLOBIN A1C received FDA 510(k) clearance on 1994-10-11, under 510(k) number K934070.

Who is the listed applicant for TINA-QUANT HEMOGLOBIN A1C?

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 HEMOGLOBIN A1C?

The FDA product code for TINA-QUANT HEMOGLOBIN A1C is LCP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 340 devices →

Related Devices (Code: LCP)

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.

K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical CorporationK231465Q-Pad Test SystemQurasenseK214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies ASK192987Aina HbA1c Monitoring System 2Jana Care, Inc.K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd.K183230OneDraw A1C Test SystemDrawbridge Health, 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.

↑