FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SELECTIVE AND DIFFERENTIAL
K Number: K841209
·
Decision Apr 17, 1984
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
12
Review Days
36
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Basic Information
- Device Name
- SELECTIVE AND DIFFERENTIAL
- K Number
- K841209
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Smith River Biologicals
- Date Received
- March 12, 1984
- Decision Date
- April 17, 1984
- Product Code
- JSI
- 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 |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | FDA class 1 | Microbiology |
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Other Clearances by Smith River Biologicals
| K Number | Device Name | ||
|---|---|---|---|
| K923892 | SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA | Jun 21, 1993 | Substantially Equivalent |
| K841207 | NON-SELECTIVE & NON-DIFFERENTIAL | Apr 17, 1984 | Substantially Equivalent |
| K841204 | MULTIPLE BIOCHEMICAL TEST | Apr 17, 1984 | Substantially Equivalent |
| K841206 | NON-SELECTIVE & DIFFERENTIAL | Apr 17, 1984 | Substantially Equivalent |
| K841211 | SELECTIVE BROTH | Apr 5, 1984 | Substantially Equivalent |
| K841208 | PROPAGATING TRANSPORT | Apr 5, 1984 | Substantially Equivalent |
| K841210 | SELECTIVE & NON-DIFFERENTIAL | Apr 4, 1984 | Substantially Equivalent |
| K841212 | SINGLE BIOCHEMICAL TEST | Apr 4, 1984 | Substantially Equivalent |
| K841213 | ANTIMICROBIAL SUSCEPT-CULTURE MEDIA | Apr 4, 1984 | Substantially Equivalent |
| K841205 | NON PROPAGATING TRANSPORT | Apr 4, 1984 | Substantially Equivalent |