FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SANDARE BCG ALBUMIN PROCEDURE
K Number: K860684
·
Decision Mar 17, 1986
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
119
Applicant Total
23
Review Days
20
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
- SANDARE BCG ALBUMIN PROCEDURE
- K Number
- K860684
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1035
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sandare Chemical Co., Inc.
- Date Received
- February 25, 1986
- Decision Date
- March 17, 1986
- Product Code
- CIX
- 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 |
|---|---|---|---|
| CIX | Bromcresol Green Dye-Binding, Albumin | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CIX), ordered by most recent decision date.
Core Metabolic
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Albumin BCG2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VITROS XT Chemistry Products ALB-TP Slides
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Sandare Chemical Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K872852 | EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST | Sep 29, 1987 | Substantially Equivalent |
| K862556 | SANDARE GLYCOHEMOGLOBIN PROCEDURE | Aug 8, 1986 | Substantially Equivalent |
| K851395 | SANDARE IRON-BINDING CAPACITY PROCEDURE | May 7, 1985 | Substantially Equivalent |
| K851394 | SANDARE IRON PROCEDURE | Apr 30, 1985 | Substantially Equivalent |
| K844498 | SANDARE ALKALINE PHOSPHATASE PROCEDURE | Dec 10, 1984 | Substantially Equivalent |
| K842516 | SANDARE ACID PHOSPHATASE PROCEDURE | Aug 17, 1984 | Substantially Equivalent |
| K833898 | TRI-LEVEL BILIRUBIN CONTROLS | Jan 13, 1984 | Substantially Equivalent |
| K832942 | TOTAL & DIRECT BILIRUBIN PROCEDURES | Nov 7, 1983 | Substantially Equivalent |
| K832632 | ALBUMIN PROCEDURE BCP | Sep 12, 1983 | Substantially Equivalent |
| K832183 | SANDARE CALCIUM PROCEDURE | Aug 24, 1983 | Substantially Equivalent |