FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COLORIMETERS SERIES ONE 12
K Number: K830101
·
Decision Jan 28, 1983
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
28
Review Days
17
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Basic Information
- Device Name
- COLORIMETERS SERIES ONE 12
- K Number
- K830101
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Innotron of Oregon, Inc.
- Date Received
- January 11, 1983
- Decision Date
- January 28, 1983
- 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 Innotron of Oregon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K903101 | INNOFLUOR (TM) AMIKACIN CALIBRATOR SET | Aug 22, 1990 | Substantially Equivalent |
| K903100 | INNOFLUOR (TM) AMIKACIN REAGENT SET | Aug 9, 1990 | Substantially Equivalent |
| K900707 | MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR | Apr 20, 1990 | Substantially Equivalent |
| K900708 | MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR | Apr 19, 1990 | Substantially Equivalent |
| K900704 | MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA | Apr 12, 1990 | Substantially Equivalent |
| K900703 | MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR | Apr 12, 1990 | Substantially Equivalent |
| K900705 | MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR | Apr 12, 1990 | Substantially Equivalent |
| K900706 | MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA | Apr 12, 1990 | Substantially Equivalent |
| K900702 | MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA | Apr 12, 1990 | Substantially Equivalent |
| K895827 | INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET | Oct 31, 1989 | Substantially Equivalent |