FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COLORIMETRIC BUN
K Number: K831414
·
Decision Jun 16, 1983
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
15
Applicant Total
19
Review Days
45
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
- COLORIMETRIC BUN
- K Number
- K831414
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bio-Analytics Laboratories, Inc.
- Date Received
- May 2, 1983
- Decision Date
- June 16, 1983
- Product Code
- CDL
- 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 |
|---|---|---|---|
| CDL | Berthelot Indophenol, Urea Nitrogen | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDL), ordered by most recent decision date.
RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COLORIMETRIC BUN REAGENT KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UREA NITROGEN(BUN), COLORIMETRIC METHOD
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UREA NITROGEN TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UREAFAST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Bio-Analytics Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861638 | KINETIC ALKALINE PHOSPHATASE REAGENT KIT | May 29, 1986 | Substantially Equivalent |
| K860245 | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | Mar 14, 1986 | Substantially Equivalent |
| K860213 | ALBUMIN REAGENT KIT | Feb 11, 1986 | Substantially Equivalent |
| K851513 | ULTRA-VIOLET BUN REAGENT KIT | May 20, 1985 | Substantially Equivalent |
| K851514 | ULTRA-VIOLET GLUCOSE REAGENT | May 20, 1985 | Substantially Equivalent |
| K850639 | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | Mar 5, 1985 | Substantially Equivalent |
| K832771 | ERYTHROCYTE TEST | Oct 28, 1983 | Substantially Equivalent |
| K832567 | ACETAMINOPHEN(PARACETAMOL | Sep 12, 1983 | Substantially Equivalent |
| K821934 | BIO-CAL OPERATION CHECK KIT | Jul 20, 1982 | Substantially Equivalent |
| K813431 | SALICYLATES | Mar 25, 1982 | Substantially Equivalent |