TINA-QUANT(R) IGG— 510(k) K862764

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K862764 for TINA-QUANT(R) IGG, Substantially Equivalent on 1986-09-03. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code DEW
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1986-07-22
Decision date: 1986-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Boehringer Mannheim Corp.

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K984419 — ELECSYS IGE CALCHECK1999-02-02
K984425 — MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR1999-01-20
K984372 — ELECSYS CALCHECK TROPONIN T1998-12-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.