FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OMNI
K Number: K925625
·
Decision Aug 19, 1993
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
37
Review Days
286
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Basic Information
- Device Name
- OMNI
- K Number
- K925625
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bio-Tek Instruments, Inc.
- Date Received
- November 6, 1992
- Decision Date
- August 19, 1993
- 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 Bio-Tek Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973609 | IDA-4 AND IPT-MC | Dec 18, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K971273 | INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF | Oct 8, 1997 | Substantially Equivalent |
| K961862 | MODELS IDA-2 PLUS AND IPT-1 | Feb 26, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K954391 | MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER | Nov 17, 1995 | Substantially Equivalent |
| K953710 | ELX808 AUTOMATED MICROPLATE READERS | Oct 25, 1995 | Substantially Equivalent |
| K953572 | ELX800UV | Oct 19, 1995 | Substantially Equivalent |
| K950104 | ELX800 AND EL800 AUTOMATED MICROPLATE READERS | Mar 21, 1995 | Substantially Equivalent |
| K942923 | CERES 900C & CERES UV900C | Feb 6, 1995 | Substantially Equivalent |
| K944257 | LIONHEART 3 MULTI-PARAMETER SIMULATOR | Sep 21, 1994 | Substantially Equivalent |
| K933519 | INDEX SPO2 SIMULATOR | Sep 1, 1994 | Substantially Equivalent |