Atlas FDA

URIC ACID/ALDH

FDA 510(k) clearance K802371 · decided 1980-10-23

Clearance details

K-number
K802371
Device name
URIC ACID/ALDH
Applicant
Boehringer Mannheim Corp.
Decision
Substantially Equivalent
Date received
1980-09-29
Decision date
1980-10-23
Days to decision
24 days
Clearance type
Traditional
Product code
CDO
Device class
1
Regulation number
862.1775
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Walker, MI, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
RANDOX URIC ACID (K033278)Randox Laboratories, Ltd.2004-02-27
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P (K992798)Sigma Diagnostics, Inc.1999-09-28
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT (K982251)Sigma Diagnostics, Inc.1998-08-18
URIC ACID (K981766)Abbott Laboratories1998-06-19
URIC ACID (K981189)Abbott Laboratories1998-05-07
URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (K971485)Trace America, Inc.1997-05-27
OLYMPUS URIC ACID REAGENT (K955752)Olympus America, Inc.1996-01-31
URIC ACID TEST ITEM NUMBER 65422 (K932162)Em Diagnostic Systems, Inc.1993-09-27
SYSTEMATE URICACID TEST, TECHNICON RA 1000 (K923765)Em Diagnostic Systems, Inc.1992-09-22
SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422 (K903335)Em Diagnostic Systems, Inc.1990-08-17
BIOTROL URIC ACID ENZYMATIQUE UV H.P. (K875320)Biotrol, USA, Inc.1988-02-01
GEMENI URIC ACID U.V. (K873358)Electro-Nucleonics Laboratories, Inc.1987-09-11

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ENZYMUN TEST{R} CEA (P860058/S001)Boehringer Mannheim Corp.1993-07-29
ENZYMUN-TEST{R} AFP (P860044/S003)Boehringer Mannheim Corp.1991-09-03
ENZYMUN-TEST{R} AFP (P860044/S002)Boehringer Mannheim Corp.1991-07-19
ENZYMUN-TEST{R} AFP (P860044/S001)Boehringer Mannheim Corp.1990-08-03
MICUR-MIC SYSTEMS (P820073)Boehringer Mannheim Corp.1983-06-29