Serum Tox Calibrator

FDA 510(k) K961372 · Diagnostic Reagents, Inc.

Substantially Equivalent

510(k) numberK961372

Submission

Device name
Serum Tox Calibrator
Applicant
Diagnostic Reagents, Inc.
Sunnyvale, CA, US
Received
April 9, 1996
Decision date
May 1, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DKB – Calibrators, Drug Mixture
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3200
Specialty
Clinical Toxicology

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More from Roche Diagnostics Corp.

510(k)DeviceDecision
K983268Modification of Tricyclic Serum Tox Eia AssayLFH · Traditional 11/18/1998SE
K983812Napa Eia AssayLAN · Traditional 11/16/1998SE
K983323Digoxin ImmunoassayKXT · Traditional 11/12/1998SE
K983280Vancomycin Eia AssayLEH · Traditional 11/06/1998SE
K983159Drugs of Abuse Urine Calibrators and ControlsDKB · Traditional 11/05/1998SE
K973102Lidocaine Eia AssayKLR · Traditional 09/12/1997SE
K97283550NG/ML Cocaine Metabolite CalibratorDLJ · Traditional 08/28/1997SE
K972526Methadone Eia AssayDJR · Traditional 08/04/1997SE
K964212Quinidine Enzyme ImmunoassayLBZ · Traditional 12/18/1996SE
K963835Digoxin Enzyme ImmunoassayKXT · Traditional 12/10/1996SE

Questions and answers

When was Serum Tox Calibrator cleared by the FDA?

Serum Tox Calibrator (K961372) received a 510(k) decision of Substantially Equivalent on May 1, 1996, 22 days after the submission was received.

What is the product code of K961372?

The FDA product code is DKB – Calibrators, Drug Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.3200.