Atlas FDA

UNICALIBRATOR KIT

FDA 510(k) clearance K922021 · decided 1992-06-09

Clearance details

K-number
K922021
Device name
UNICALIBRATOR KIT
Applicant
American Bioproducts Co.
Decision
Substantially Equivalent
Date received
1992-04-30
Decision date
1992-06-09
Days to decision
40 days
Clearance type
Traditional
Product code
GIZ
Device class
2
Regulation number
864.5425
Medical specialty
Hematology
Advisory committee
Hematology
Location
Parsippany, NJ, 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
STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW (K060968)Wortham Laboratories, Inc.2007-05-15
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REFERENCE CHECK, CATALOG NUMBER-RCN-10 (K013708)Precision Biologic2001-12-10
ACCUCLOT CONTROL I, MODEL A4089 (K003328)Sigma Diagnostics, Inc.2001-03-01
CONTROL PLASMA N (K001256)Dade Behring, Inc.2000-05-24
COAGULATION CONTROL LEVEL 1 (NORMAL) (K984129)Pacific Hemostasis1998-12-01
ACCUCOLOR HIGH CALIBRATOR (A3089) (K973274)Sigma Diagnostics, Inc.1997-10-31
THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS (K961814)Cardiovascular Diagnostics, Inc.1996-08-13
SPECIALTY ASSAYED CONTROL-1 (K941737)Helena Laboratories1994-10-07
DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA (K935254)American Diagnostica, Inc.1994-09-19
CONTROL PLASMA N (K924403)Behring Diagnostics, Inc.1994-02-22

Recalls involving this device

RecordFirmDate
STA UNICALIBRATOR (ref. 00675) recall (Z-0737-2020)Diagnostica Stago, Inc.2019-12-23