FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TITAN GEL CPK/LDH ISOENZYME CONTROL
K Number: K821981
·
Decision Jul 22, 1982
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
96
Applicant Total
280
Review Days
16
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
- TITAN GEL CPK/LDH ISOENZYME CONTROL
- K Number
- K821981
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Helena Laboratories
- Date Received
- July 6, 1982
- Decision Date
- July 22, 1982
- 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 Helena Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K131479 | V8 SP NORMAL CONTROL, ABNORMAL CONTROL | Oct 7, 2013 | Substantially Equivalent |
| K100103 | SPECIALTY ASSAYED CONTROL-2 | Dec 15, 2010 | Substantially Equivalent |
| K061991 | PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA | Feb 23, 2007 | Substantially Equivalent |
| K061069 | SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 | Jul 6, 2006 | Substantially Equivalent |
| K061014 | ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP | May 10, 2006 | Substantially Equivalent |
| K050053 | HEMORAM/AGGRAM ANALYZER | Jul 11, 2005 | Substantially Equivalent |
| K024162 | SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 | Feb 19, 2003 | Substantially Equivalent |
| K023761 | PLATELETWORKS, MODELS PW-A, PW-C | Feb 14, 2003 | Substantially Equivalent |
| K022757 | SPIFE CK KIT, MODEL 3332, 3333 | Oct 11, 2002 | Substantially Equivalent |
| K022455 | SPIFE LD-12 KIT, MODEL 3338 | Oct 1, 2002 | Substantially Equivalent |