FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPECTROPHOTOMETER (MICROASSAY PLATE READERS)
K Number: K902776
·
Decision Jul 31, 1990
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
9
Review Days
36
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Basic Information
- Device Name
- SPECTROPHOTOMETER (MICROASSAY PLATE READERS)
- K Number
- K902776
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Slt Labinstruments, Inc.
- Date Received
- June 25, 1990
- Decision Date
- July 31, 1990
- 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 Slt Labinstruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K915690 | SLT 340 ATTC | Apr 22, 1992 | Substantially Equivalent |
| K915689 | SLT SPECTRA | Apr 22, 1992 | Substantially Equivalent |
| K881797 | EASY WASHER II MICROPLATE WASHER | Jun 15, 1988 | Substantially Equivalent |
| K873678 | SPECTROPHOTOMETER (MICROASSAY PLATE READERS) | Sep 29, 1987 | Substantially Equivalent |
| K844894 | PHOTOMETER VARIOUS ONE FOR MICROTITERPLATES | Jun 25, 1985 | Substantially Equivalent |
| K844893 | SLT 223 DISPENSER FOR MICROTITERPLATES | Feb 25, 1985 | Substantially Equivalent |
| K844892 | SLT 220 WASHER FOR MICROITITERPLATES | Feb 25, 1985 | Substantially Equivalent |
| K844891 | SLT 225 WASHER/DISPENSER FOR MICRO TITERPLATES | Feb 25, 1985 | Substantially Equivalent |