FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RAPID SST
K Number: K821040
·
Decision May 3, 1982
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
243
Applicant Total
21
Review Days
20
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Basic Information
- Device Name
- RAPID SST
- K Number
- K821040
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Mds Laboratories, Inc.
- Date Received
- April 13, 1982
- Decision Date
- May 3, 1982
- Product Code
- JTO
- 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 |
|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | FDA class 1 | Microbiology |
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Other Clearances by Mds Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K864251 | SELENITE F. BROTH | Mar 31, 1987 | Substantially Equivalent |
| K864255 | TRYPTICASE SOY BROTH | Mar 31, 1987 | Substantially Equivalent |
| K864238 | CHOCOLATE AGAR | Mar 31, 1987 | Substantially Equivalent |
| K864240 | COLUMBIA BLOOD AGAR WITH 5% SHEEP BLOOD | Mar 31, 1987 | Substantially Equivalent |
| K864241 | DNASE AGAR | Mar 31, 1987 | Substantially Equivalent |
| K864244 | GARNERELLA VAGINALIS IDENTIFICATION KIT | Mar 31, 1987 | Substantially Equivalent |
| K864239 | CLED AGAR WITH ANDRADES INDICATOR | Mar 31, 1987 | Substantially Equivalent |
| K864254 | THIOGLYCOLLATE BROTH | Mar 31, 1987 | Substantially Equivalent |
| K864237 | CARY BLAIR TRANSPORT MEDIUM | Mar 31, 1987 | Substantially Equivalent |
| K864246 | MUELLER HINTON AGAR LARGE | Mar 31, 1987 | Substantially Equivalent |