FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAGNESIUM REAGENT SET
K Number: K855190
·
Decision Feb 18, 1986
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
89
Applicant Total
21
Review Days
54
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Basic Information
- Device Name
- MAGNESIUM REAGENT SET
- K Number
- K855190
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1495
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Technostics Intl.
- Date Received
- December 26, 1985
- Decision Date
- February 18, 1986
- 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 Technostics Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K855188 | CPK (UV) REAGENT KIT | Mar 5, 1986 | Substantially Equivalent |
| K860111 | URIC ACID REAGENT SET | Feb 19, 1986 | Substantially Equivalent |
| K860110 | GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET | Feb 11, 1986 | Substantially Equivalent |
| K860109 | ENZYMATIC UREA NITROGEN REAGENT SET | Feb 6, 1986 | Substantially Equivalent |
| K860112 | TOTAL LIPIDS REAGENT SET | Jan 24, 1986 | Substantially Equivalent |
| K855185 | GLUCOSE REAGENT SET | Jan 22, 1986 | Substantially Equivalent |
| K855157 | LACTIC DEHYDROGENASE (VV) REAGENT SET | Jan 21, 1986 | Substantially Equivalent |
| K855194 | GLUCOSE OXIDASE REAGENT SET | Jan 14, 1986 | Substantially Equivalent |
| K855153 | GLUCOSE (UV HEXOKIASE) REAGENT SET | Jan 14, 1986 | Substantially Equivalent |
| K855193 | CREATININE REAGENT SET | Jan 14, 1986 | Substantially Equivalent |