FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MYREADER 7
K Number: K853284
·
Decision Oct 4, 1985
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
11
Review Days
60
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Basic Information
- Device Name
- MYREADER 7
- K Number
- K853284
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Scientific Sales Intl., Inc.
- Date Received
- August 5, 1985
- Decision Date
- October 4, 1985
- Product Code
- JJQ
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | FDA class 1 | Clinical Chemistry |
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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 |
| 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 |