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FDA 510(k)

RAMP PROGESTURINE PDG ASSAY--48 TEST KIT

K-Number: K860924 · 1986-07-02

ApplicantMonoclonal Antibodies, Inc.
Decision Date1986-07-02
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAMP PROGESTURINE PDG ASSAY--48 TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Monoclonal Antibodies, Inc.. It received FDA 510(k) clearance on 1986-07-02 under 510(k) number K860924. 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 RAMP PROGESTURINE PDG ASSAY--48 TEST KIT?

RAMP PROGESTURINE PDG ASSAY--48 TEST KIT is a medical device that received FDA 510(k) clearance on 1986-07-02. The listed applicant is Monoclonal Antibodies, Inc.. The 510(k) number is K860924.

When did RAMP PROGESTURINE PDG ASSAY--48 TEST KIT receive FDA 510(k) clearance?

RAMP PROGESTURINE PDG ASSAY--48 TEST KIT received FDA 510(k) clearance on 1986-07-02, under 510(k) number K860924.

Who is the listed applicant for RAMP PROGESTURINE PDG ASSAY--48 TEST KIT?

The FDA 510(k) record lists Monoclonal Antibodies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAMP PROGESTURINE PDG ASSAY--48 TEST KIT?

The FDA product code for RAMP PROGESTURINE PDG ASSAY--48 TEST KIT is JLS.

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Other records listing Monoclonal Antibodies, 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.

K874863RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)K871726OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)K863744HCG CONTROL KITK854611RAMP URINE HCG ASSAYK850730MODEL SERUM HCG ASSAYK850480OVU STICK SELF-TEST -MODIFICATION

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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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