FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)
K Number: K883387
·
Decision Oct 13, 1988
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
10
Applicant Total
36
Review Days
64
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Basic Information
- Device Name
- ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)
- K Number
- K883387
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1030
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Tech-Co, Inc.
- Date Received
- August 10, 1988
- Decision Date
- October 13, 1988
- Product Code
- CKD
- 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 |
|---|---|---|---|
| CKD | Hydrazone Colorimetry, Alt/Sgpt | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CKD), ordered by most recent decision date.
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REFLOTRON(R) ALT (GPT)
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SGPT (ALT) REAGENT SET (COLORIMETRIC)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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 |
| K883683 | HEMOGLOBIN | Oct 6, 1988 | Substantially Equivalent |
| K883386 | CHLORIDE | Oct 6, 1988 | Substantially Equivalent |
| K881172 | BILIRUBIN (DIRECT) | Jun 7, 1988 | Substantially Equivalent |
| K881173 | ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) | Jun 7, 1988 | Substantially Equivalent |