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FDA 510(k)

AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144

K-Number: K884100 · 1988-11-10

ApplicantAmersham Corp.
Decision Date1988-11-10
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144 is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1988-11-10 under 510(k) number K884100. The device is classified under product code JLS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144?

AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144 is a medical device that received FDA 510(k) clearance on 1988-11-10. The listed applicant is Amersham Corp.. The 510(k) number is K884100.

When did AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144 receive FDA 510(k) clearance?

AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144 received FDA 510(k) clearance on 1988-11-10, under 510(k) number K884100.

Who is the listed applicant for AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144?

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 PROGESTERONE ASSAY, LAN.0079/2079 240/144?

The FDA product code for AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144 is JLS.

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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: JLS)

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.

K040923LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVAIbl GmbHK973898PROGESTERONE ELISAKmi Diagnostics, Inc.K972133VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)Johnson & Johnson Clinical Diagnostics, Inc.K971725OPUS PROGESTERONEBehring Diagnostics, Inc.K964841ELECSYS PROGESTERONE ASSAYBoehringer Mannheim Corp.K965084VIDAS PROESTERONE (PRG) (30 409)bioMerieux, 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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