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System Pack for B.M.D/Hitachi 704 Chem. Ana.(GABA)

by Boehringer Mannheim Corp.

510(k) K872306

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK872306 Date18 Aug 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CIC
Device Class
Class II
Regulation
21 CFR Part 862.1145
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a system pack for the B.M.D/Hitachi 704 chemical analyzer, intended for the measurement of GABA (gamma-aminobutyric acid) in clinical chemistry applications. It is classified under the product code CIC as a Cresolphthalein Complexone, Calcium test system, which is used to measure total calcium levels in serum.

The device received FDA 510(k) clearance (K872306) on August 18, 1987, and was found substantially equivalent to a predicate device. It is manufactured by Boehringer Mannheim Corp. in Indianapolis, Indiana, and is regulated as a Class II medical device under regulation number 862.1145 with special controls. The device is supplied as a system pack for use with the Hitachi 704 analyzer in clinical laboratory settings.

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