FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAGNESIUM KIT
K Number: K810084
·
Decision Jan 26, 1981
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
89
Applicant Total
19
Review Days
13
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Basic Information
- Device Name
- MAGNESIUM KIT
- K Number
- K810084
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1495
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bio-Analytics Laboratories, Inc.
- Date Received
- January 13, 1981
- Decision Date
- January 26, 1981
- Product Code
- JGJ
- 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 |
|---|---|---|---|
| JGJ | Photometric Method, Magnesium | FDA class 1 | 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 |
| K821934 | BIO-CAL OPERATION CHECK KIT | Jul 20, 1982 | Substantially Equivalent |