Atlas FDA

IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN

FDA 510(k) clearance K831961 · decided 1983-08-11

Clearance details

K-number
K831961
Device name
IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN
Applicant
Kent Laboratories, Inc.
Decision
Substantially Equivalent
Date received
1983-06-17
Decision date
1983-08-11
Days to decision
55 days
Clearance type
Traditional
Product code
JBQ
Device class
2
Regulation number
864.7060
Medical specialty
Hematology
Advisory committee
Hematology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Kent Laboratories

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
INNOVANCE Antithrombin (K242952)Siemens Healthcare Diagnostic Products GmbH2025-03-28
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 (K081769)Siemens Healthcare Diagnostics2009-05-28
HEMOSIL ANTITHROMBIN (K070301)Instrumentation Laboratory CO2007-02-23
HEMOSIL LIQUID ANTITHROMBIN (K062431)Instrumentation Laboratory CO2006-09-01
BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 (K043007)Hyphen Biomed2005-11-07
HEMOSIL LIQUID ANTITHROMBIN XL (K033775)Instrumentation Laboratory CO2004-01-02
CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 (K023991)Precision Biologic2003-04-28
COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS (K022550)Instrumentation Laboratory CO2002-08-27
COAMATIC AT-400 (K022195)Instrumentation Laboratory CO2002-08-07
IL TEST LIQUID ANTITHROMBIN (K994238)Instrumentation Laboratory CO2000-06-23
K-ASSAY AT-III (K000361)Kamiya Biomedical Co.2000-04-26
IL TEST ANTITHROMBIN (K980499)Instrumentation Laboratory CO1998-04-02

Recalls involving this device

No recalls on record reference this clearance.