FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CELL
K Number: K780305
·
Decision Mar 27, 1978
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
3
Applicant Total
44
Review Days
32
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Basic Information
- Device Name
- CELL
- K Number
- K780305
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2240
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Dynatech Laboratories, Inc.
- Date Received
- February 23, 1978
- Decision Date
- March 27, 1978
- Product Code
- KJF
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| KJF | System, Suspension, Cell Culture | FDA class 1 | Hematology |
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| 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 |
| 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 |