FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENZYMATIC ALPHA-AMYLASE REAGENT KIT
K Number: K850639
·
Decision Mar 5, 1985
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
7
Applicant Total
19
Review Days
14
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Basic Information
- Device Name
- ENZYMATIC ALPHA-AMYLASE REAGENT KIT
- K Number
- K850639
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1070
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bio-Analytics Laboratories, Inc.
- Date Received
- February 19, 1985
- Decision Date
- March 5, 1985
- Product Code
- CIW
- 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 |
|---|---|---|---|
| CIW | Starch-Dye Bound Polymer, Amylase | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CIW), ordered by most recent decision date.
DMA AMYLASE PROCEDURE
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OLYMPUS AMYLASE REAGENT
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AMYLASE TEST (AMYL) ITEM NUMBER: 65653
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KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)
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PHADEBAS ISOAMYLASE TEST
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PANTRAK E.K.
FDA 510(k)
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·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 |
| K832771 | ERYTHROCYTE TEST | Oct 28, 1983 | Substantially Equivalent |
| K832567 | ACETAMINOPHEN(PARACETAMOL | Sep 12, 1983 | Substantially Equivalent |
| K831414 | COLORIMETRIC BUN | Jun 16, 1983 | Substantially Equivalent |
| K821934 | BIO-CAL OPERATION CHECK KIT | Jul 20, 1982 | Substantially Equivalent |
| K813431 | SALICYLATES | Mar 25, 1982 | Substantially Equivalent |