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FDA 510(k)

NATAL-TEC PROGESTERONE

K-Number: K811369 · 1981-05-29

ApplicantArmkel, LLC
Decision Date1981-05-29
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NATAL-TEC PROGESTERONE is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1981-05-29 under 510(k) number K811369. 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 NATAL-TEC PROGESTERONE?

NATAL-TEC PROGESTERONE is a medical device that received FDA 510(k) clearance on 1981-05-29. The listed applicant is Armkel, LLC. The 510(k) number is K811369.

When did NATAL-TEC PROGESTERONE receive FDA 510(k) clearance?

NATAL-TEC PROGESTERONE received FDA 510(k) clearance on 1981-05-29, under 510(k) number K811369.

Who is the listed applicant for NATAL-TEC PROGESTERONE?

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

What is the FDA product code for NATAL-TEC PROGESTERONE?

The FDA product code for NATAL-TEC PROGESTERONE is JLS.

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Other records listing Armkel, LLC 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.

K040866FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TESTK030258FIRST RESPONSE PREGNANCY TESTK023405TROJAN MINT TINGLE BRAND LATEX CONDOMSK013433TROJAN PASSION BERRY GELK013614TROJAN CRYSTAL CLEAR LIQUIDK001212TROJAN EXTRA LARGE LATEX CONDOM

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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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