FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THROMBOPLASTIN.C PLUS
K Number: K901325
·
Decision May 2, 1990
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
126
Applicant Total
505
Review Days
42
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- THROMBOPLASTIN.C PLUS
- K Number
- K901325
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7750
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Baxter Healthcare Corp
- Date Received
- March 21, 1990
- Decision Date
- May 2, 1990
- Product Code
- GJS
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GJS | Test, Time, Prothrombin | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GJS), ordered by most recent decision date.
CoaguChek XS Plus System
FDA 510(k)
FDA Class 2
·Hematology
microINR System
FDA 510(k)
FDA Class 2
·Hematology
microINR System
FDA 510(k)
FDA Class 2
·Hematology
Xprecia Prime Coagulation System
FDA 510(k)
FDA Class 2
·Hematology
i-STAT PTplus Cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Hematology
microINR System
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Baxter Healthcare Corp
| K Number | Device Name | ||
|---|---|---|---|
| K190910 | PrisMax System Version 2 | Jul 25, 2019 | Substantially Equivalent |
| K163530 | PrisMax Control Unit | May 3, 2017 | Substantially Equivalent |
| K130531 | ULTRAFUSE | Apr 8, 2014 | Substantially Equivalent |
| K132734 | NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS | Oct 8, 2013 | Substantially Equivalent |
| K130245 | LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO | Mar 1, 2013 | Substantially Equivalent |
| K123874 | INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S | Jan 10, 2013 | Substantially Equivalent |
| K123868 | INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET | Jan 8, 2013 | Substantially Equivalent |
| K121092 | FLOWEASE [SUBCUTANEOUS] INFUSION SET | Jun 29, 2012 | Substantially Equivalent |
| K113227 | NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER | Dec 8, 2011 | Substantially Equivalent |
| K111217 | ADDITIVE CAP | Jun 14, 2011 | Substantially Equivalent |