FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MYWASHER 5
K Number: K853285
·
Decision Oct 4, 1985
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
42
Applicant Total
11
Review Days
60
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Basic Information
- Device Name
- MYWASHER 5
- K Number
- K853285
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Scientific Sales Intl., Inc.
- Date Received
- August 5, 1985
- Decision Date
- October 4, 1985
- Product Code
- LIB
- 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 |
|---|---|---|---|
| LIB | Device, General Purpose, Microbiology, Diagnostic | 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 |
| K853284 | MYREADER 7 | Oct 4, 1985 | Substantially Equivalent |
| K853380 | SPR 2 AUTODILUTER | Sep 12, 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 |