FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROSCO PYRR
K Number: K894221
·
Decision Sep 28, 1989
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
243
Applicant Total
27
Review Days
101
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Basic Information
- Device Name
- ROSCO PYRR
- K Number
- K894221
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Pro-Lab, Inc.
- Date Received
- June 19, 1989
- Decision Date
- September 28, 1989
- 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 Pro-Lab, Inc.
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|---|---|---|---|
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| K903714 | E. COLI 0157 LATEX TEST | Jan 24, 1991 | Substantially Equivalent |
| K883995 | X-ACT UREA/TDA | Oct 12, 1988 | Substantially Equivalent |
| K883996 | X-ACT LDC/IND | Oct 12, 1988 | Substantially Equivalent |
| K871121 | PROTECT T.M. | Apr 14, 1987 | Substantially Equivalent |
| K870117 | NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST | Mar 20, 1987 | Substantially Equivalent |
| K861142 | MASTER KIT B | Jul 10, 1986 | Unknown |
| K861888 | HIPPURATE HYDROLYSIS TEST | Jun 3, 1986 | Substantially Equivalent |