FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICRO-FLOW SPECTROPHOTOMETER CL-720
K Number: K801957
·
Decision Sep 26, 1980
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
257
Applicant Total
23
Review Days
39
Basic Information
- Device Name
- MICRO-FLOW SPECTROPHOTOMETER CL-720
- K Number
- K801957
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- SHIMADZU PRECISION INSTRUMENTS, INC.
- Date Received
- August 18, 1980
- Decision Date
- September 26, 1980
- 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 SHIMADZU PRECISION INSTRUMENTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
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| K890913 | SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT | Sep 6, 1989 | Substantially Equivalent |
| K884598 | SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200 | Apr 20, 1989 | Substantially Equivalent |
| K884477 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B | Mar 15, 1989 | Substantially Equivalent |
| K875378 | SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION | Nov 16, 1988 | Substantially Equivalent |
| K882311 | SHIMADZU LATERAL C-ARM MH-31 | Sep 14, 1988 | Substantially Equivalent |
| K881674 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC | Sep 2, 1988 | Substantially Equivalent |
| K881795 | SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K | Jul 1, 1988 | Substantially Equivalent |
| K874910 | SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-200 | Jul 1, 1988 | Substantially Equivalent |
| K875370 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX | May 18, 1988 | Substantially Equivalent |