510(k) K844164
- Device
- REACTIFS, IBF ULTROGELS ACA & ULTROGELS A
- Applicant
- LKB INSTRUMENTS, INC.
- 510(k) number
- K844164
- Product code
- DII
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-12-10
- Date received
- 1984-10-25
- Regulation
- 862.2250
- Classification name
- Columns, Glc
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ED ZIOR
- Address
- 9319 Gaither Rd. Gaithersburg MD US 20877 20877
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DII #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K874824 | CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY | Supelco, Inc. | 1988-01-21 |
| K862542 | CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY | Supelco, Inc. | 1986-08-04 |
| K841712 | CAPILLARY GAS CHROMATOGRAPHIC COLUMNS | Supelco, Inc. | 1984-05-21 |
| K791893 | 19091-XXXXX SER. OF GLASS CAPILLARY COL. | Hewlett-Packard Co. | 1979-10-30 |
Legacy Summary#
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FDA Review#
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