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FDA 510(k)

LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE

K-Number: K872727 · 1987-08-05

ApplicantSerono Diagnostics, Inc.
Decision Date1987-08-05
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE 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 1987-08-05 under 510(k) number K872727. 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. PHASE?

LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE is a medical device that received FDA 510(k) clearance on 1987-08-05. The listed applicant is Serono Diagnostics, Inc.. The 510(k) number is K872727.

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

LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE received FDA 510(k) clearance on 1987-08-05, under 510(k) number K872727.

Who is the listed applicant for LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE?

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. PHASE?

The FDA product code for LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE 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.

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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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