FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TITAN GEL REP SIMULTANEOUS CK-LD ISOENZYME PROCED.
K Number: K874140
·
Decision Nov 3, 1987
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
122
Applicant Total
280
Review Days
21
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 REP SIMULTANEOUS CK-LD ISOENZYME PROCED.
- K Number
- K874140
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Helena Laboratories
- Date Received
- October 13, 1987
- Decision Date
- November 3, 1987
- Product Code
- CGS
- 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 |
|---|---|---|---|
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGS), ordered by most recent decision date.
Pointe Scientific Creatinine Kinase (CK) Reagent Set
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SEKURE Creatine Kinase Assay
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CPK REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·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 |