FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SINGLE AND DUAL BAND DIPSTICK HCG TEST
K Number: K893873
·
Decision Aug 21, 1989
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
71
Applicant Total
15
Review Days
87
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Basic Information
- Device Name
- SINGLE AND DUAL BAND DIPSTICK HCG TEST
- K Number
- K893873
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Ampcor, Inc.
- Date Received
- May 26, 1989
- Decision Date
- August 21, 1989
- Product Code
- DHA
- 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 |
|---|---|---|---|
| DHA | System, Test, Human Chorionic Gonadotropin | FDA class 2 | Clinical Chemistry |
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Other Clearances by Ampcor, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K922297 | INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST | Jul 14, 1992 | Substantially Equivalent |
| K922296 | IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST | Jul 14, 1992 | Substantially Equivalent |
| K910438 | DIPSTICK SALMONELLA | Sep 13, 1991 | Substantially Equivalent |
| K890048 | QUIK-DOT TOXOPLASMOSIS | Jun 9, 1989 | Substantially Equivalent |
| K892146 | C REACTIVE PROTEIN LIQUID | Apr 14, 1989 | Substantially Equivalent |
| K892119 | QUIK-DOT C REACTIVE PROTEIN | Apr 14, 1989 | Substantially Equivalent |
| K890025 | QUIK-DOT ANTISTREPTOLYSIN-O | Jan 31, 1989 | Substantially Equivalent |
| K884750 | GROUP A STREP, BETA-STREP | Dec 22, 1988 | Substantially Equivalent |
| K880163 | PREGNANCY (HCG) CARD & LIQUID TEST | May 17, 1988 | Substantially Equivalent |
| K880478 | PREGNANCY BETA-HCG CARD & LIQUID TEST | Apr 28, 1988 | Substantially Equivalent |