FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BCG ALBUMIN REAGET
K Number: K781441
·
Decision Oct 10, 1978
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
119
Applicant Total
12
Review Days
50
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Basic Information
- Device Name
- BCG ALBUMIN REAGET
- K Number
- K781441
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1035
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Analytical & Research Chemicals, Inc.
- Date Received
- August 21, 1978
- Decision Date
- October 10, 1978
- 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 |
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Other Clearances by Analytical & Research Chemicals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823806 | DIRECT CREATININE PROCEDURE | Jan 14, 1983 | Substantially Equivalent |
| K823786 | ALKALINE PHOSPHATASE | Jan 14, 1983 | Substantially Equivalent |
| K823784 | ENZYMATIC CHOLESTEROL (COLORIMETRIC | Jan 14, 1983 | 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 |