FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-CAL OPERATION CHECK KIT
K Number: K821934
·
Decision Jul 20, 1982
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
129
Applicant Total
19
Review Days
21
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Basic Information
- Device Name
- BIO-CAL OPERATION CHECK KIT
- K Number
- K821934
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bio-Analytics Laboratories, Inc.
- Date Received
- June 29, 1982
- Decision Date
- July 20, 1982
- Product Code
- JIS
- 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 |
|---|---|---|---|
| JIS | Calibrator, Primary | FDA class 2 | Clinical Chemistry |
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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 |
| K831414 | COLORIMETRIC BUN | Jun 16, 1983 | Substantially Equivalent |
| K813431 | SALICYLATES | Mar 25, 1982 | Substantially Equivalent |