FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
120 WELL HISTO-PLATE
K Number: K790958
·
Decision Jun 28, 1979
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
7
Applicant Total
44
Review Days
37
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Basic Information
- Device Name
- 120 WELL HISTO-PLATE
- K Number
- K790958
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2240
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Dynatech Laboratories, Inc.
- Date Received
- May 22, 1979
- Decision Date
- June 28, 1979
- Product Code
- KIZ
- 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 |
|---|---|---|---|
| KIZ | Dish, Tissue 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 |