510(k) K913196
- Device
- KODAK EKTACHEM DT SLIDES (LIPASE)
- Applicant
- EASTMAN KODAK COMPANY
- 510(k) number
- K913196
- Product code
- CHT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-09-25
- Date received
- 1991-07-18
- Regulation
- 862.1165
- Classification name
- Electrophoretic Method, Catecholamines
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- NORMAN H GEIL
- Address
- 343 State St. Rochester NY US 14650 14650
FDA Registration Numbers#
- 3010361165
- 2381321
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CHT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K760920 | CAT-A-KIT | The Upjohn Co. | 1976-11-09 |
Legacy Summary#
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FDA Review#
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