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FDA 510(k)

AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST

K-Number: K881142 · 1988-07-21

ApplicantAmersham Corp.
Decision Date1988-07-21
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1988-07-21 under 510(k) number K881142. 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 AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST?

AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST is a medical device that received FDA 510(k) clearance on 1988-07-21. The listed applicant is Amersham Corp.. The 510(k) number is K881142.

When did AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST receive FDA 510(k) clearance?

AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST received FDA 510(k) clearance on 1988-07-21, under 510(k) number K881142.

Who is the listed applicant for AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST?

The FDA 510(k) record lists Amersham Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST?

The FDA product code for AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST is CGJ.

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Other records listing Amersham Corp. 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.

K914135AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086K912733AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KITK912766AMERLITE CK-MB ASSAYK904666AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008K902760AMERSHAM TSH CONTROL SERAK901832GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415

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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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