FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SLT MICROPLATE WASHER
K Number: K910740
·
Decision Mar 27, 1991
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
257
Applicant Total
6
Review Days
34
Basic Information
- Device Name
- SLT MICROPLATE WASHER
- K Number
- K910740
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- TECAN U.S., LTD.
- Date Received
- February 21, 1991
- Decision Date
- March 27, 1991
- Product Code
- JJQ
- 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by TECAN U.S., LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K933996 | PROFIBLOT | Jan 28, 1994 | Substantially Equivalent |
| K915492 | RSP MEGA SAMPLE PROCESSOR | Feb 21, 1992 | Substantially Equivalent |
| K912036 | ROBOTIC SAMPLE PROCESSOR | Jul 26, 1991 | Substantially Equivalent |
| K894126 | ROBOTIC SAMPLE PROCESSOR | Aug 15, 1989 | Substantially Equivalent |
| K854406 | TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500 | Feb 10, 1986 | Substantially Equivalent |