FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPR 2 AUTODILUTER
K Number: K853380
·
Decision Sep 12, 1985
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
65
Applicant Total
11
Review Days
31
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Basic Information
- Device Name
- SPR 2 AUTODILUTER
- K Number
- K853380
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2500
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Scientific Sales Intl., Inc.
- Date Received
- August 12, 1985
- Decision Date
- September 12, 1985
- Product Code
- JTC
- 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 |
|---|---|---|---|
| JTC | Device, Microtiter Diluting/Dispensing | FDA class 1 | Microbiology |
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Other Clearances by Scientific Sales Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K953677 | LIGHTED FLEXGUIDE (MODIFICATION) | Aug 25, 1995 | Substantially Equivalent |
| K940799 | FLEXGUIDE | Aug 18, 1994 | Substantially Equivalent |
| K860996 | SANASSAY IC TEST | Mar 30, 1987 | Substantially Equivalent |
| K862087 | SANTEST 1AP | Dec 3, 1986 | Substantially Equivalent |
| K861336 | IAP PLATE TEST | Apr 25, 1986 | Substantially Equivalent |
| K853285 | MYWASHER 5 | Oct 4, 1985 | Substantially Equivalent |
| K853284 | MYREADER 7 | Oct 4, 1985 | Substantially Equivalent |
| K853379 | PLATE INCUBATOR | Sep 3, 1985 | Substantially Equivalent |
| K833022 | AIR UTERINE DISPLACER-AUD 120 | Oct 14, 1983 | Substantially Equivalent |
| K802416 | SALEM/RESCE INTUBATION GUIDE | Oct 23, 1980 | Substantially Equivalent |