FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DETECT-A-STREP
K Number: K843590
·
Decision Oct 30, 1984
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
104
Applicant Total
16
Review Days
48
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Basic Information
- Device Name
- DETECT-A-STREP
- K Number
- K843590
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Antibodies, Inc.
- Date Received
- September 12, 1984
- Decision Date
- October 30, 1984
- 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 Antibodies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K890774 | GIARDEIA(TM) | Apr 4, 1989 | Substantially Equivalent |
| K822892 | CORTISOL RIA KIT | Nov 1, 1982 | Substantially Equivalent |
| K812749 | ULTRA-DIG | Oct 19, 1981 | Substantially Equivalent |
| K812314 | CRITHIDNA ANTI-DNA TEST KIT | Sep 1, 1981 | Substantially Equivalent |
| K802877 | AMIKACIN RIA KIT | Dec 19, 1980 | Substantially Equivalent |
| K800743 | TOBRAMYCIN RIA KIT | Apr 16, 1980 | Substantially Equivalent |
| K791217 | TSH RIA KIT | Sep 4, 1979 | Substantially Equivalent |
| K781655 | NEPHELRATE ANTISERUMS 1GA | Nov 8, 1978 | Substantially Equivalent |
| K781654 | NEPHELRATE ANTIPERUMS LGM | Nov 8, 1978 | Substantially Equivalent |
| K781656 | NEPHELRATE ANTISERUMS, IGG | Nov 8, 1978 | Substantially Equivalent |