FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DILUTER/DISPENSER
K Number: K780882
·
Decision Jun 28, 1978
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
139
Applicant Total
22
Review Days
29
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Basic Information
- Device Name
- DILUTER/DISPENSER
- K Number
- K780882
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2750
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Innovative Medical Systems, Inc.
- Date Received
- May 30, 1978
- Decision Date
- June 28, 1978
- Product Code
- JQW
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | FDA class 1 | Clinical Chemistry |
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| K915457 | PHACO 20/20 SYSTEM I | Feb 24, 1992 | Substantially Equivalent |
| K915456 | PHACO 3000 LINEAR | Feb 12, 1992 | Substantially Equivalent |
| K883599 | LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) | Sep 2, 1988 | Substantially Equivalent |
| K880745 | LX-100 SLIDE STAINER | Apr 27, 1988 | Substantially Equivalent |