510(k) K895828
- Device
- INNOFLUOR DIGOXIN REAGENT SET
- Applicant
- INNOTRON OF OREGON, INC.
- 510(k) number
- K895828
- Product code
- LCS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-10-30
- Date received
- 1989-10-02
- Regulation
- 862.3320
- Classification name
- Radioimmunoassay, Digoxin (125-i)
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CRAIG SMART
- Address
- 4432 Se16th.Ave. Portland OR US 97202 97202
FDA Registration Numbers#
- 2029372
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LCS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K922353 | DIGOXIN COATED TUBE RIA | Monobind | 1992-08-24 |
| K913562 | QMS - DIGOXIN | Seradyn, Inc. | 1991-08-30 |
| K884707 | FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT | Cyberfluor, Inc. | 1989-01-17 |
| K874748 | IMMPULSE DIGOXIN ASSAY REAGENTS | Sclavo, Inc. | 1988-02-19 |
| K864802 | DART DIGOXIN ASSAY | Coulter Electronics, Inc. | 1987-02-12 |
| K820154 | TDX DIGOXIN | Abbott Laboratories | 1982-02-05 |
| K812749 | ULTRA-DIG | Antibodies, Inc. | 1981-10-19 |
| K803047 | I-125 LABELED DIGOXIN | Pcl-Ria, Inc. | 1980-12-22 |
| K801490 | DIGOXIN EIA KIT | M.A. Bioproducts | 1980-07-14 |
| K801413 | AMERLEX DIGOXIN RIA KIT | Amersham Corp. | 1980-07-08 |
| K801202 | DIGOXIN RADIOIMMUNOASSAY KIT | Technia Diagnostics , Ltd. | 1980-06-20 |
| K800997 | DIGOXIN CLASP RIA KIT | E. R. Squibb & Sons, Inc. | 1980-05-08 |
| K800773 | DIGOCTK 125 | Sorin Biomedica, Fiat, USA, Inc. | 1980-04-24 |
| K770322 | PHALDEBAS DIGOXIN RIA | Pharmacia, Inc. | 1977-04-05 |
Legacy Summary#
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FDA Review#
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