Quantitative Determination of Porphyrins

FDA 510(k) K780455 · Whale Scientific, Inc.

Substantially Equivalent

510(k) numberK780455

Submission

Device name
Quantitative Determination of Porphyrins
Applicant
Whale Scientific, Inc.
Mchenry, IL, US
Received
March 20, 1978
Decision date
July 27, 1978
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
K871499Protofluor ZJKJ · Traditional Helena Laboratories08/25/1987SE

More from Helena Laboratories

510(k)DeviceDecision
K855214CAT-3 Catecholamine Assay KitCHQ · Traditional 03/14/1986SE
K841506META-3 · Traditional 04/11/1984SESP

Questions and answers

When was Quantitative Determination of Porphyrins cleared by the FDA?

Quantitative Determination of Porphyrins (K780455) received a 510(k) decision of Substantially Equivalent on July 27, 1978, 129 days after the submission was received.

What is the product code of K780455?

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