FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CLINISTAT TRIGLYCERIDES REAGENT TEST
K Number: K885134
·
Decision Feb 10, 1989
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
21
Applicant Total
145
Review Days
60
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
- CLINISTAT TRIGLYCERIDES REAGENT TEST
- K Number
- K885134
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1705
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Heraeus Kulzer, Inc.
- Date Received
- December 12, 1988
- Decision Date
- February 10, 1989
- Product Code
- JGY
- 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 |
|---|---|---|---|
| JGY | Colorimetric Method, Triglycerides | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JGY), ordered by most recent decision date.
PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PICCOLO TRIGLYCERIDES TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BIOSCANNER TRIGLYCERIDES TEST STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BIOSCANNER TRIGLYCERIDES TEST STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TRIGLYCERIDES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TRIGLYCERIDES REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Heraeus Kulzer, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K091494 | FLEXITIME FLOW | Jul 31, 2009 | Substantially Equivalent |
| K063062 | HKBOND 2006 | Dec 1, 2006 | Substantially Equivalent |
| K060994 | MONDIAL | May 22, 2006 | Substantially Equivalent |
| K052543 | HERACERAM ZIRKONIA | Oct 25, 2005 | Substantially Equivalent |
| K043504 | PALAIMPACT | Jan 28, 2005 | Substantially Equivalent |
| K043295 | VERSYO.DIRECT | Jan 5, 2005 | Substantially Equivalent |
| K042878 | FLEXITIME XTREME | Dec 17, 2004 | Substantially Equivalent |
| K030052 | OSTIM | Dec 6, 2004 | Substantially Equivalent |
| K040859 | HERACERAM PRESS | May 20, 2004 | Substantially Equivalent |
| K040043 | NDX-40 ALLOY | Mar 3, 2004 | Substantially Equivalent |