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FDA 510(k)

LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA

K-Number: K882340 · 1988-08-08

ApplicantSerono Diagnostics, Inc.
Decision Date1988-08-08
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA is the device name listed in this FDA 510(k) record. The listed applicant is Serono Diagnostics, Inc.. It received FDA 510(k) clearance on 1988-08-08 under 510(k) number K882340. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA?

LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA is a medical device that received FDA 510(k) clearance on 1988-08-08. The listed applicant is Serono Diagnostics, Inc.. The 510(k) number is K882340.

When did LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA receive FDA 510(k) clearance?

LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA received FDA 510(k) clearance on 1988-08-08, under 510(k) number K882340.

Who is the listed applicant for LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA?

The FDA 510(k) record lists Serono Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA?

The FDA product code for LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA is CEP.

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Other records listing Serono Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K953598SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERSK942051SR1 DHEA-S ENZYME IMMUNOASSAYK883085T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHASK880388T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASEK874866T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASEK873431PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH

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Related Devices (Code: CEP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K013582MAYBE?MOM MINI OVULATION MICROSCOPEMaybe?MomK022829INSTANT-VIEW LH OVULATION PREDICTING TESTAlfa Scientific Designs, Inc.K021409AT HOME OVULATION TEST, MODEL 9032Phamatech, Inc.K013874CLEARPLANE EASY OVULATION TESTUnipath , Ltd.K013323TCI-31 LIFELONG OVULATION TESTERTci New YorkK012252QUIK-CHECK OVULATION PREDICTORACON Laboratories, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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