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FDA 510(k)

PAP-TRAY II (CATALOG #C600-2)

K-Number: K761001 · 1976-12-06

ApplicantLerner Laboratories, Inc.
Decision Date1976-12-06
Product CodeLEA
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

PAP-TRAY II (CATALOG #C600-2) is the device name listed in this FDA 510(k) record. The listed applicant is Lerner Laboratories, Inc.. It received FDA 510(k) clearance on 1976-12-06 under 510(k) number K761001. The device is classified under product code LEA. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PAP-TRAY II (CATALOG #C600-2)?

PAP-TRAY II (CATALOG #C600-2) is a medical device that received FDA 510(k) clearance on 1976-12-06. The listed applicant is Lerner Laboratories, Inc.. The 510(k) number is K761001.

When did PAP-TRAY II (CATALOG #C600-2) receive FDA 510(k) clearance?

PAP-TRAY II (CATALOG #C600-2) received FDA 510(k) clearance on 1976-12-06, under 510(k) number K761001.

Who is the listed applicant for PAP-TRAY II (CATALOG #C600-2)?

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

What is the FDA product code for PAP-TRAY II (CATALOG #C600-2)?

The FDA product code for PAP-TRAY II (CATALOG #C600-2) is LEA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Lerner Laboratories, 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.

K854083XYLENE SUBSTITUTE MONTANTK853694XYLENE SUBSTITUTEK821443FORMICALK761000PAP-TRAY I (CATALOG #C600-1)

Related Devices (Code: LEA)

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.

K873594TIF FECAL TESTDevetec, Inc.K770592CYTOLOGY FIXATIVESurgipath Medical Industries, Inc.K761000PAP-TRAY I (CATALOG #C600-1)Lerner Laboratories, 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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