Protofluor Z

FDA 510(k) K871499 · Helena Laboratories

Substantially Equivalent

510(k) numberK871499

Submission

Device name
Protofluor Z
Applicant
Helena Laboratories
Beaumont, TX, US
Received
April 16, 1987
Decision date
August 25, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JKJ – Fluorometric Measurement, Porphyrins
Device class
Class I (low risk)
Regulation
21 CFR 862.1595
Specialty
Clinical Chemistry

Other 510(k)s with product code JKJ

510(k)DeviceApplicantDecision
K893038Protofluor ZJKJ · Traditional Helena Laboratories11/17/1989SE
K780455Quantitative Determination of PorphyrinsJKJ · Traditional Whale Scientific, Inc.07/27/1978SE

More from Whale Scientific, Inc.

510(k)DeviceDecision
K213396SPIFE A1AT kitOBZ · Traditional 10/13/2022SE
K192931V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlGKA · Traditional 04/19/2022SE
K131479V8 SP Normal Control, Abnormal ControlJJY · Traditional 10/07/2013SE
K100103Specialty Assayed CONTROL-2GGC · Traditional 12/15/2010SE
K061991Plateletworks Arachidonic Acid, Model Pw-AcaGHR · Traditional 02/23/2007SE
K061069Spife IFE-15 Pentavalent, Model 3456, Spife IFE-9 Pentavalent Kit, Model 3457, Spift…CFF · Traditional 07/06/2006SE
K061014Actalyke QC Kit, Models Aqc-Hp and Aqc-LpJPA · Special 05/10/2006SE
K050053Hemoram/Aggram AnalyzerJPA · Traditional 07/11/2005SE
K024162Spife 3000 Titan Gel Igg Ief Kit, Model 3389CFF · Traditional 02/19/2003SE
K023761Plateletworks, Models Pw-A, Pw-CJOZ · Traditional 02/14/2003SE

Questions and answers

When was Protofluor Z cleared by the FDA?

Protofluor Z (K871499) received a 510(k) decision of Substantially Equivalent on August 25, 1987, 131 days after the submission was received.

What is the product code of K871499?

The FDA product code is JKJ – Fluorometric Measurement, Porphyrins, a Class I (low risk) device regulated under 21 CFR 862.1595.