FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DADE(R) CK-MB IMMUNOASSAY CONTROL
K Number: K882795
·
Decision Aug 29, 1988
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
96
Applicant Total
503
Review Days
54
Basic Information
- Device Name
- DADE(R) CK-MB IMMUNOASSAY CONTROL
- K Number
- K882795
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- BAXTER HEALTHCARE CORP.
- Date Received
- July 6, 1988
- Decision Date
- August 29, 1988
- Product Code
- JJT
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JJT | Enzyme Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJT), ordered by most recent decision date.
SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by BAXTER HEALTHCARE CORP.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K102936 | HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R | Mar 30, 2011 | Substantially Equivalent |
| K103551 | INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS, | Mar 25, 2011 | Substantially Equivalent |