Lacti-Quant

FDA 510(k) K801849 · Nuclear Medical Laboratories, Inc.

Substantially Equivalent

510(k) numberK801849

Submission

Device name
Lacti-Quant
Applicant
Nuclear Medical Laboratories, Inc.
Mchenry, IL, US
Received
August 4, 1980
Decision date
September 16, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CFT – Radioimmunoassay, Prolactin (Lactogen)
Device class
Class I (low risk)
Regulation
21 CFR 862.1625
Specialty
Clinical Chemistry

Other 510(k)s with product code CFT

510(k)DeviceApplicantDecision
K971921Prolactin (PRL) Hormone Microplate ElisaCFT · Traditional Monobind06/24/1997SE
K970281Vitros Immunodiagnostic Products Prolactin Reagent Pack/CalibratorsCFT · Traditional Johnson & Johnson Clinical Diagnostics, Inc.02/25/1997SE
K970188Sealite Sciences, Inc. Aqualite ProlactinCFT · Traditional Sealite Sciences, Inc.02/20/1997SE
K964748Elecsys Prolactin AssayCFT · Traditional Boehringer Mannheim Corp.01/21/1997SE
K960561DSL Active Prolactin Elisa Model 10-4500CFT · Traditional Diagnostic Systems Laboratories, Inc.04/26/1996SE
K960060DSL Active Prolactin IrmaCFT · Traditional Diagnostic Systems Laboratories, Inc.02/29/1996SE
K954680Access Prolactin Assay (Modification)CFT · Traditional Bio-Rad Laboratories, Inc.10/20/1995SE
K953656Abbott Imx Prolactin(Modification)CFT · Traditional Abbott Mfg., Inc.10/03/1995SE
K953657Abbott Axsym Prolactin(Modification)CFT · Traditional Abbott Mfg., Inc.09/25/1995SE
K944698Auraflex Prolactin 200 Test Pack, Calibrator Pack, Dilvent 1CFT · Traditional Organon Teknika Corp.03/21/1995SE

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K832892Modified Chorio-ShureJHI · Traditional 10/28/1983SE
K832002NML-5010/5020 Multi-Detector SystemJJJ · Traditional 08/08/1983SE
K823679NML 6000 CTJQP · Traditional 01/07/1983SE
K823053Nml-Tetra-Tube RiaCDX · Traditional 11/10/1982SE
K822298Diagnostic Radioimmunoassay for QuantiJFH · Traditional 09/02/1982SE
K820523Chorio-QuantJHI · Traditional 03/15/1982SE

Questions and answers

When was Lacti-Quant cleared by the FDA?

Lacti-Quant (K801849) received a 510(k) decision of Substantially Equivalent on September 16, 1980, 43 days after the submission was received.

What is the product code of K801849?

The FDA product code is CFT – Radioimmunoassay, Prolactin (Lactogen), a Class I (low risk) device regulated under 21 CFR 862.1625.