510(k) K884176
- Device
- CHROMATOGRAPHY KIT
- Applicant
- GELMAN SCIENCES, INC.
- 510(k) number
- K884176
- Product code
- DPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-04-04
- Date received
- 1988-10-04
- Regulation
- 862.2270
- Classification name
- Apparatus, General Use, Thin Layer Chromatography
- Medical specialty
- Clinical Chemistry
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANGELO PEREIRA
- Address
- 600 S Wagner Rd. Ann Arbor MI US 48103 48103
FDA Registration Numbers#
- 2245285
- 1932270
- 3002800697
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DPA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K904326 | DE-TOX TUBES A AND DE-TOX TUBES B | Dyna-Tek Industries | 1991-01-17 |
| K791431 | TECHNICON FAST-LC SYS. FOR THEOPHYLLINE | Technicon Instruments Corp. | 1979-10-11 |
| K770765 | REAGENT SET, RENORPACE | G.D. Searle and Co. | 1977-06-24 |
| K760908 | MINIATURE ASCENDING PAPER CHROMATO- | Ackerman Nuclear, Inc. | 1976-11-19 |
Legacy Summary#
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FDA Review#
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