FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST
K Number: K921968
·
Decision Jun 28, 1996
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
95
Applicant Total
36
Review Days
1523
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Basic Information
- Device Name
- IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST
- K Number
- K921968
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tech-Co, Inc.
- Date Received
- April 27, 1992
- Decision Date
- June 28, 1996
- Product Code
- JHJ
- 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 |
|---|---|---|---|
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | FDA class 2 | Clinical Chemistry |
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Other Clearances by Tech-Co, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K881173 | ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) | Jun 7, 1988 | Substantially Equivalent |