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FDA 510(k)

FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH

K-Number: K872627 · 1987-07-21

ApplicantSerono Diagnostics, Inc.
Decision Date1987-07-21
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH 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 1987-07-21 under 510(k) number K872627. The device is classified under product code CGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH?

FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH is a medical device that received FDA 510(k) clearance on 1987-07-21. The listed applicant is Serono Diagnostics, Inc.. The 510(k) number is K872627.

When did FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH receive FDA 510(k) clearance?

FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH received FDA 510(k) clearance on 1987-07-21, under 510(k) number K872627.

Who is the listed applicant for FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH?

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 FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH?

The FDA product code for FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH is CGJ.

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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 PHASK882340LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHAK880388T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASEK874866T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE

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Related Devices (Code: CGJ)

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.

K052662ONE STEP FSH MENOPAUSAL TESTInd Diagnostic, Inc.K043599MOMENTS MENOPAUSE CHECK, MODEL 9113Phamatech, Inc.K041165FSH MENOPAUSE PREDICTOR TESTACON Laboratories, Inc.K040575PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112Phamatech, Inc.K030058EARLYDETECT MENOPAUSE TEST FOR FSHEarly Detect, Inc.K002450GENUA MENOPAUSE MONITOR TEST KITGenua 1944, 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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