FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SYNALON ROLLER BOTTLE
K Number: K791049
·
Decision Jun 28, 1979
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
2
Applicant Total
44
Review Days
22
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Basic Information
- Device Name
- SYNALON ROLLER BOTTLE
- K Number
- K791049
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2240
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Dynatech Laboratories, Inc.
- Date Received
- June 6, 1979
- Decision Date
- June 28, 1979
- Product Code
- KJC
- 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 |
|---|---|---|---|
| KJC | Bottle, Roller, Tissue Culture | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KJC), ordered by most recent decision date.
MULTISURFACE ROLLER BOTTLE (M.S.R.B.)
FDA 510(k)
FDA Class 1
·Hematology
IN VITRO 2.5X ROLLER BOTTLE
FDA 510(k)
FDA Class 1
·Hematology
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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 |