FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CK REAGENT CARTRIDGE (PRODUCT NO. 88213)
K Number: K861879
·
Decision May 29, 1986
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
122
Applicant Total
52
Review Days
14
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
- CK REAGENT CARTRIDGE (PRODUCT NO. 88213)
- K Number
- K861879
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Hi Chem, Inc.
- Date Received
- May 15, 1986
- Decision Date
- May 29, 1986
- 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 Hi Chem, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960084 | HICHEM GLUCOSE/HK REAGENT KIT | Apr 4, 1996 | Substantially Equivalent |
| K951818 | HICHEM ALT REAGENT KIT | May 15, 1995 | Substantially Equivalent |
| K943684 | HICHEM ENZYME VERIFIER KIT | Oct 4, 1994 | Substantially Equivalent |
| K941764 | HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 | May 13, 1994 | Substantially Equivalent |
| K902673 | HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND | Jul 17, 1990 | Substantially Equivalent |
| K863617 | ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) | Oct 24, 1986 | Substantially Equivalent |
| K862027 | LDP REAGENT CARTRIDGE (NO. 88216) | Jun 13, 1986 | Substantially Equivalent |
| K861893 | GGT REAGENT CARTRIDGE (PRODUCT NO. 88204) | Jun 5, 1986 | Substantially Equivalent |
| K861284 | AP REAGENT CARTRIDGE | Apr 28, 1986 | Substantially Equivalent |
| K861231 | ALT REAGENT CARTRIDGE (PRODUCT NO. 88210) | Apr 28, 1986 | Substantially Equivalent |