FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRE BUFFER CRE DYE
K Number: K851993
·
Decision May 30, 1985
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
158
Applicant Total
33
Review Days
23
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
- CRE BUFFER CRE DYE
- K Number
- K851993
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Alpkem Corp.
- Date Received
- May 7, 1985
- Decision Date
- May 30, 1985
- Product Code
- CGX
- 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 |
|---|---|---|---|
| CGX | Alkaline Picrate, Colorimetry, Creatinine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGX), ordered by most recent decision date.
Nova Allegro UACR Assay, Nova Allegro Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Tru Kidney Health Test Panel; Tru Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Atellica® CH Creatinine_3 (Crea3)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Nova Allegro UACR Assay, Nova Allegro Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Creatinine2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Alpkem Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K894011 | TOTAL GALACTOSE | Jan 11, 1990 | Substantially Equivalent |
| K891070 | PHENYLALANINE (NINHYDRIN REACTION) | Oct 27, 1989 | Substantially Equivalent |
| K890334 | TOTAL CHOLESTEROL REAGENT | May 3, 1989 | Substantially Equivalent |
| K890337 | TRIGLYCERIDES - GPO REAGENT | Mar 9, 1989 | Substantially Equivalent |
| K890336 | GLUCOSE (GOD) REAGENT | Feb 27, 1989 | Substantially Equivalent |
| K890332 | RFA/2 RAPID FLOW ANALYZER W/COMPUTER | Feb 17, 1989 | Substantially Equivalent |
| K890335 | SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. | Feb 17, 1989 | Substantially Equivalent |
| K890333 | ALBUMIN REAGENT | Feb 17, 1989 | Substantially Equivalent |
| K883020 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER | Sep 2, 1988 | Substantially Equivalent |
| K860367 | MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) | Apr 11, 1986 | Substantially Equivalent |