FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICROLITE MICROTITER PLATE LUMINOMETER ML2200
K Number: K920888
·
Decision Mar 19, 1992
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
37
Applicant Total
44
Review Days
37
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Basic Information
- Device Name
- MICROLITE MICROTITER PLATE LUMINOMETER ML2200
- K Number
- K920888
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2560
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dynatech Laboratories, Inc.
- Date Received
- February 11, 1992
- Decision Date
- March 19, 1992
- Product Code
- KHO
- 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 |
|---|---|---|---|
| KHO | Fluorometer, For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Dynatech Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962265 | MLX MICROTITER PLATE LUMINOMETER | Jul 25, 1996 | Substantially Equivalent |
| K934111 | MR7000 WITH TIME MANAGER SOFTWARE (TMS) | Nov 2, 1994 | Substantially Equivalent |
| K943701 | MRX MICROPLATE READER | Oct 20, 1994 | Substantially Equivalent |
| K923456 | MICROLITE MICROTITER PLATE LUMINOMETER ML3000 | Oct 13, 1992 | Substantially Equivalent |
| K915896 | MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI | May 4, 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 |
| K890502 | MICROLITE TUBE LUMINOMETER #011-902-0000 | Feb 27, 1989 | Substantially Equivalent |