FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIRECT CREATININE PROCEDURE
K Number: K823806
·
Decision Jan 14, 1983
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
158
Applicant Total
12
Review Days
29
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
- DIRECT CREATININE PROCEDURE
- K Number
- K823806
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Analytical & Research Chemicals, Inc.
- Date Received
- December 16, 1982
- Decision Date
- January 14, 1983
- 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 Analytical & Research Chemicals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823786 | ALKALINE PHOSPHATASE | Jan 14, 1983 | Substantially Equivalent |
| K823784 | ENZYMATIC CHOLESTEROL (COLORIMETRIC | Jan 14, 1983 | Substantially Equivalent |
| K781441 | BCG ALBUMIN REAGET | Oct 10, 1978 | Substantially Equivalent |
| K781460 | CHLORIDE REAGENT | Oct 10, 1978 | Substantially Equivalent |
| K781307 | GLUCOSE DETERM. KIT | Aug 31, 1978 | Substantially Equivalent |
| K781309 | GOT PROCEDURE | Aug 31, 1978 | Substantially Equivalent |
| K781323 | LDH PROCEDURE | Aug 31, 1978 | Substantially Equivalent |
| K781306 | UREA NITROGEN TEST KIT | Aug 31, 1978 | Substantially Equivalent |
| K781305 | UREA NITROGEN | Aug 31, 1978 | Substantially Equivalent |
| K781308 | GLUCOLOUR | Aug 31, 1978 | Substantially Equivalent |