FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GROUP A STREP, BETA-STREP
K Number: K884750
·
Decision Dec 22, 1988
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
104
Applicant Total
15
Review Days
38
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Basic Information
- Device Name
- GROUP A STREP, BETA-STREP
- K Number
- K884750
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Ampcor, Inc.
- Date Received
- November 14, 1988
- Decision Date
- December 22, 1988
- Product Code
- GTZ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| GTZ | Antisera, All Groups, Streptococcus Spp. | FDA class 1 | Microbiology |
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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 |
| K893873 | SINGLE AND DUAL BAND DIPSTICK HCG TEST | Aug 21, 1989 | 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 |
| K880163 | PREGNANCY (HCG) CARD & LIQUID TEST | May 17, 1988 | Substantially Equivalent |
| K880478 | PREGNANCY BETA-HCG CARD & LIQUID TEST | Apr 28, 1988 | Substantially Equivalent |