FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES
K Number: K854423
·
Decision Nov 20, 1985
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
42
Applicant Total
44
Review Days
15
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Basic Information
- Device Name
- IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES
- K Number
- K854423
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Dynatech Laboratories, Inc.
- Date Received
- November 5, 1985
- Decision Date
- November 20, 1985
- Product Code
- LIB
- 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 |
|---|---|---|---|
| LIB | Device, General Purpose, Microbiology, Diagnostic | FDA class 1 | Microbiology |
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| K923456 | MICROLITE MICROTITER PLATE LUMINOMETER ML3000 | Oct 13, 1992 | Substantially Equivalent |
| K915896 | MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI | May 4, 1992 | Substantially Equivalent |
| K920888 | MICROLITE MICROTITER PLATE LUMINOMETER ML2200 | Mar 19, 1992 | Substantially Equivalent |
| K913590 | MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER | Oct 25, 1991 | Substantially Equivalent |
| K895313 | MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER | Oct 17, 1989 | Substantially Equivalent |
| K894645 | IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM | Oct 17, 1989 | Substantially Equivalent |
| K894687 | DYNATECH MR 5000, CATALOG #011-976-0600 | Aug 31, 1989 | Substantially Equivalent |