FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHOSPHORUS (INORGANIC)
K Number: K881171
·
Decision Apr 28, 1988
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
104
Applicant Total
36
Review Days
38
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Basic Information
- Device Name
- PHOSPHORUS (INORGANIC)
- K Number
- K881171
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1580
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Tech-Co, Inc.
- Date Received
- March 21, 1988
- Decision Date
- April 28, 1988
- Product Code
- CEO
- 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 |
|---|---|---|---|
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | FDA class 1 | Clinical Chemistry |
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WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
FDA 510(k)
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Other Clearances by Tech-Co, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K921968 | IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST | Jun 28, 1996 | Substantially Equivalent |
| K923376 | VISUAL HCG PREGNANCY TEST | Oct 1, 1992 | Substantially Equivalent |
| K920766 | T4 EIA BEAD ASSAY | Apr 17, 1992 | Substantially Equivalent |
| K920716 | DIRECT PREGNANCY TEST | Mar 24, 1992 | Substantially Equivalent |
| K902574 | POTASSIUM REAGENT SET | Jul 10, 1990 | Substantially Equivalent |
| K901561 | IRON/TOTAL IRON BINDING CAPACITY | May 17, 1990 | Substantially Equivalent |
| K883387 | ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) | Oct 13, 1988 | Substantially Equivalent |
| K883683 | HEMOGLOBIN | Oct 6, 1988 | Substantially Equivalent |
| K883386 | CHLORIDE | Oct 6, 1988 | Substantially Equivalent |
| K881172 | BILIRUBIN (DIRECT) | Jun 7, 1988 | Substantially Equivalent |