FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STREPTO-SEC TM
K Number: K801159
·
Decision Jun 20, 1980
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
104
Applicant Total
41
Review Days
40
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Basic Information
- Device Name
- STREPTO-SEC TM
- K Number
- K801159
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Organon, Inc.
- Date Received
- May 11, 1980
- Decision Date
- June 20, 1980
- 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 Organon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950861 | RECONSTITUTION ACCESSOREIS | May 26, 1995 | Substantially Equivalent |
| K853388 | MONOSTICON UNI-DOT | Aug 22, 1985 | Substantially Equivalent |
| K842314 | DUOCLON COLOR-CEPT | Aug 24, 1984 | Substantially Equivalent |
| K841525 | OREIA II B-HCG PREGNANCY TEST KIT | Jun 5, 1984 | Substantially Equivalent |
| K841602 | ACCURATE BETA 30 PREGNANCY TEST KIT | May 22, 1984 | Substantially Equivalent |
| K840650 | B-NEOCEPT 30 | Apr 4, 1984 | Substantially Equivalent |
| K832801 | OREIA II B-HCG, ENZYME INNUNOASSAY | Dec 8, 1983 | Substantially Equivalent |
| K831339 | NEO-PREGNOSTICON DUOCLON TUBE TEST | Jun 8, 1983 | Substantially Equivalent |
| K831109 | DUOCLON SLIDE TEST | Jun 2, 1983 | Substantially Equivalent |
| K823682 | BETA FFIRM TEST | Jan 7, 1983 | Substantially Equivalent |