Atlas FDA

STA-VWF CALIBRATOR KIT

FDA 510(k) clearance K962671 · decided 1996-09-13

Clearance details

K-number
K962671
Device name
STA-VWF CALIBRATOR KIT
Applicant
American Bioproducts Co.
Decision
Substantially Equivalent
Date received
1996-07-09
Decision date
1996-09-13
Days to decision
66 days
Clearance type
Traditional
Product code
GJT
Device class
2
Regulation number
864.7290
Medical specialty
Hematology
Advisory committee
Hematology
Location
Parisppany, NJ, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch American Bioproducts Co.

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
CRYOcheck Factor VIII Deficient Plasma with VWF (K222831)Precision Biologic, Inc.2023-09-13
HemosIL Factor XII Deficient Plasma (K180486)Instrumentation Laboratory CO2018-03-22
NOFACT IX (K102908)R2 Diagnostics, Inc.2011-12-19
NOFACT VIII (K102851)R2 Diagnostics, Inc.2011-12-19
HEMOSIL FACTOR VIII DEFICIENT PLASMA (K110237)Instrumentation Laboratory CO2011-07-08
HEMOSIL FACTOR II DEFICIENT PLASMA (K050661)Instrumentation Laboratory CO2005-05-02
HEMOSIL FACTOR XII DEFICIENT PLASMA (K043459)Instrumentation Laboratory CO2005-02-09
DIAPHARMA FACTOR X KIT (K040362)Diapharma Group, Inc.2004-07-12
HEMOSIL FACTOR VIII DEFICIENT PLASMA (K034007)Instrumentation Laboratory CO2004-02-13
HEMOSIL FACTOR IX DEFICIENT PLASMA (K031829)Instrumentation Laboratory CO2003-07-31
HEMOSIL FACTOR X DEFICIENT PLASMA (K031122)Instrumentation Laboratory CO2003-05-19
HEMOSIL FACTOR XI DEFICIENT PLASMA (K030287)Instrumentation Laboratory CO2003-03-19

Recalls involving this device

No recalls on record reference this clearance.