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FDA 510(k)

AMERLEX HUMAN PLACENTAL LACTOGEN

K-Number: K840588 · 1984-04-04

ApplicantAmersham Corp.
Decision Date1984-04-04
Product CodeJMF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLEX HUMAN PLACENTAL LACTOGEN is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1984-04-04 under 510(k) number K840588. The device is classified under product code JMF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERLEX HUMAN PLACENTAL LACTOGEN?

AMERLEX HUMAN PLACENTAL LACTOGEN is a medical device that received FDA 510(k) clearance on 1984-04-04. The listed applicant is Amersham Corp.. The 510(k) number is K840588.

When did AMERLEX HUMAN PLACENTAL LACTOGEN receive FDA 510(k) clearance?

AMERLEX HUMAN PLACENTAL LACTOGEN received FDA 510(k) clearance on 1984-04-04, under 510(k) number K840588.

Who is the listed applicant for AMERLEX HUMAN PLACENTAL LACTOGEN?

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 AMERLEX HUMAN PLACENTAL LACTOGEN?

The FDA product code for AMERLEX HUMAN PLACENTAL LACTOGEN is JMF.

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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: JMF)

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.

K944933IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN)Diagnostic Products Corp.K823292IMMOPHASE TM HPL RADIOIMMUNOASSAYCorning Medical & ScientificK823201HUMAN PLACENTAL LACTOGEN KITDiagnostic Products Corp.K811370NATAL-TEC HPLArmkel, LLCK802454GESTE FOLLOW KIT DETERM. OF HPLSyn-Kit, Inc.K791854CENTRIA HPL RIAUnion Carbide Corp.

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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