FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIO-TEK AUTOMATED MICROPLATE WASHER EL402
K Number: K850249
·
Decision Mar 13, 1985
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
65
Applicant Total
37
Review Days
50
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BIO-TEK AUTOMATED MICROPLATE WASHER EL402
- K Number
- K850249
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2500
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Bio-Tek Instruments, Inc.
- Date Received
- January 22, 1985
- Decision Date
- March 13, 1985
- Product Code
- JTC
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| JTC | Device, Microtiter Diluting/Dispensing | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JTC), ordered by most recent decision date.
FILTERMATE UNIVERSAL HARVESTER
FDA 510(k)
FDA Class 1
·Microbiology
MICROMATE 196 MODEL A961960
FDA 510(k)
FDA Class 1
·Microbiology
IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM
FDA 510(k)
FDA Class 1
·Microbiology
MULTI-PROBE HEAD PLUS
FDA 510(k)
FDA Class 1
·Microbiology
GENETIC SYSTEMS PIPETTOR/DILUTOR
FDA 510(k)
FDA Class 1
·Microbiology
GENETIC SYSTEMS MICROPLATE STRIP WASHER
FDA 510(k)
FDA Class 1
·Microbiology
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 |