FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STREP A OIA
K Number: K915758
·
Decision Jan 30, 1992
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
104
Applicant Total
70
Review Days
38
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Basic Information
- Device Name
- STREP A OIA
- K Number
- K915758
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biosearch Medical Products, Inc.
- Date Received
- December 23, 1991
- Decision Date
- January 30, 1992
- 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 Biosearch Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051480 | ENTERAL FEEDING TUBE | Oct 12, 2005 | Substantially Equivalent |
| K970145 | PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE) | Aug 11, 1997 | Substantially Equivalent |
| K964871 | BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS | Mar 3, 1997 | Substantially Equivalent |
| K951260 | URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT | Sep 27, 1995 | Substantially Equivalent |
| K944614 | MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM | Apr 5, 1995 | Substantially Equivalent |
| K932295 | NON-BALLOON REPLACEMENT GASTROSTOMY KIT | Sep 8, 1994 | Substantially Equivalent |
| K935045 | BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER | Aug 19, 1994 | Substantially Equivalent |
| K923002 | ENTEROCLYSIS TUBE | Jun 28, 1994 | Unknown |
| K934193 | CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST | Nov 19, 1993 | Substantially Equivalent |
| K922987 | LAPSTICK LAPAROSCOPIC SPONGE STICK/ BLUNT DISSEC. | Apr 23, 1993 | Substantially Equivalent |