510(k) K770322
- Device
- PHALDEBAS DIGOXIN RIA
- Applicant
- Pharmacia, Inc.
- 510(k) number
- K770322
- Product code
- LCS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-04-05
- Date received
- 1977-02-17
- Regulation
- 862.3320
- Classification name
- Radioimmunoassay, Digoxin (125-I)
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
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 |
| K895828 | INNOFLUOR DIGOXIN REAGENT SET | Innotron of Oregon, Inc. | 1989-10-30 |
| 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 |