FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE DISPENSE MANIFOLD
K Number: K823218
·
Decision Nov 16, 1982
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
65
Applicant Total
44
Review Days
19
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Basic Information
- Device Name
- DISPOSABLE DISPENSE MANIFOLD
- K Number
- K823218
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2500
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Dynatech Laboratories, Inc.
- Date Received
- October 28, 1982
- Decision Date
- November 16, 1982
- 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 |
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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 |
| 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 |