Opus Digitoxin

FDA 510(k) K935229 · Pb Diagnostic Systems, Inc.

Substantially Equivalent

510(k) numberK935229

Submission

Device name
Opus Digitoxin
Applicant
Pb Diagnostic Systems, Inc.
Westwood, MA, US
Received
November 1, 1993
Decision date
December 22, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DPG – Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3300
Specialty
Clinical Toxicology

Other 510(k)s with product code DPG

510(k)DeviceApplicantDecision
K812129Coat-A-Count Digitoxin Ria KitDPG · Traditional Diagnostic Products Corp.08/13/1981SE
K780075Rialyze DigoxinDPG · Traditional Miles Laboratories, Inc.02/28/1978SE

More from Miles Laboratories, Inc.

510(k)DeviceDecision
K940507Opus FT4 Test SystemCEC · Traditional 07/28/1994SE
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K933389Opus Cmv-GLFZ · Traditional 06/28/1994SE
K934137Opus(R) Serology Controls, ModificationMJX · Traditional 03/07/1994SE
K934705Opus NapaLAN · Traditional 11/22/1993SE
K933675Opus Total CKCGS · Traditional 09/08/1993SE
K933066Opus EstradiolCHP · Traditional 09/08/1993SE
K932279Opus(R) Total B-Hcg Test SystemJHI · Traditional 07/08/1993SE
K926131Opus Magnum AnalyzerKHO · Traditional 06/07/1993SE
K924957Opus(R) VancomycinLEH · Traditional 12/11/1992SE

Questions and answers

When was Opus Digitoxin cleared by the FDA?

Opus Digitoxin (K935229) received a 510(k) decision of Substantially Equivalent on December 22, 1993, 51 days after the submission was received.

What is the product code of K935229?

The FDA product code is DPG – Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep., a Class II (moderate risk) device regulated under 21 CFR 862.3300.