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Dac-Cel Diagnatal

by Burroughs Wellcome Co. 510(k)

Active United States

510(k) K810214

Overview

The DAC-CEL DIAGNATAL is a visual pregnancy HCG test device intended for prescription use, classified under the Clinical Chemistry specialty. It is a Class II medical device that received FDA 510(k) clearance as substantially equivalent to a predicate device.

The device was cleared under regulation number 862.1155 with product code JHI, following a traditional 510(k) submission reviewed by the Clinical Chemistry advisory committee. It is manufactured by Burroughs Wellcome Co. and was granted clearance on March 6, 1981, after submission on January 27, 1981.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK810214 Date6 Mar 1981ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JHI
Device Class
Class II
Regulation
21 CFR Part 862.1155
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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