FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)
K Number: K860367
·
Decision Apr 11, 1986
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
5
Applicant Total
33
Review Days
67
Basic Information
- Device Name
- MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)
- K Number
- K860367
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1445
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- ALPKEM CORP.
- Date Received
- February 3, 1986
- Decision Date
- April 11, 1986
- Product Code
- JGF
- 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 |
|---|---|---|---|
| JGF | Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes | FDA class 2 | Clinical Chemistry |
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Other Clearances by ALPKEM CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K894011 | TOTAL GALACTOSE | Jan 11, 1990 | Substantially Equivalent |
| K891070 | PHENYLALANINE (NINHYDRIN REACTION) | Oct 27, 1989 | Substantially Equivalent |
| K890334 | TOTAL CHOLESTEROL REAGENT | May 3, 1989 | Substantially Equivalent |
| K890337 | TRIGLYCERIDES - GPO REAGENT | Mar 9, 1989 | Substantially Equivalent |
| K890336 | GLUCOSE (GOD) REAGENT | Feb 27, 1989 | Substantially Equivalent |
| K890335 | SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. | Feb 17, 1989 | Substantially Equivalent |
| K890332 | RFA/2 RAPID FLOW ANALYZER W/COMPUTER | Feb 17, 1989 | Substantially Equivalent |
| K890333 | ALBUMIN REAGENT | Feb 17, 1989 | Substantially Equivalent |
| K883020 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER | Sep 2, 1988 | Substantially Equivalent |
| K852002 | CA BUFFER CA DYE | Jun 25, 1985 | Substantially Equivalent |