FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PREGNA-TEC
K Number: K832918
·
Decision Nov 3, 1983
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
95
Applicant Total
7
Review Days
70
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Basic Information
- Device Name
- PREGNA-TEC
- K Number
- K832918
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Medilab Corp.
- Date Received
- August 25, 1983
- Decision Date
- November 3, 1983
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JHJ), ordered by most recent decision date.
PREGNACOL PREGNANCY TEST
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IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST
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SAS(TM) MONOCLONAL HCG-SLIDE
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DIRECT PREGNANCY TEST
FDA 510(k)
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·Clinical Chemistry
Other Clearances by Medilab Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K841862 | IMMU-TEC | Jun 13, 1984 | Substantially Equivalent |
| K841863 | MONO-TEC | Jun 13, 1984 | Substantially Equivalent |
| K840291 | MCS ALBUMIN REAGENT | Mar 30, 1984 | Substantially Equivalent |
| K840290 | MCS TOTAL PROTEIN REAGENT | Mar 30, 1984 | Substantially Equivalent |
| K840289 | LYSE-TEC | Mar 5, 1984 | Substantially Equivalent |
| K832527 | PREGNA-TEC | Sep 12, 1983 | Substantially Equivalent |