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FDA 510(k)

AUTOLET

K-Number: K801815 · 1980-10-10

ApplicantUlster Scientific, Inc.
Decision Date1980-10-10
Product CodeJCA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AUTOLET is the device name listed in this FDA 510(k) record. The listed applicant is Ulster Scientific, Inc.. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K801815. The device is classified under product code JCA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOLET?

AUTOLET is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Ulster Scientific, Inc.. The 510(k) number is K801815.

When did AUTOLET receive FDA 510(k) clearance?

AUTOLET received FDA 510(k) clearance on 1980-10-10, under 510(k) number K801815.

Who is the listed applicant for AUTOLET?

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

What is the FDA product code for AUTOLET?

The FDA product code for AUTOLET is JCA.

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Other records listing Ulster Scientific, 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.

K942620FEATHER-TOUCH SINGLE-STICK DEVICEK920562UNISTIKK902592EPC ELECTRONIC PIPETTING SYSTEMK895890AUTOPENK894474THE AUTOLET LITEK885340AIR DISPLACEMENT PIPETTE

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Related Devices (Code: JCA)

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.

K911745SIMPLATE PEDIATRICOrganon Teknika Corp.K911996SURGICUTT-BLEEDING TIME DEVICE, MODIFICATIONInternational Technidyne Corp.K871318Q.I.C. BLEEDING TIME DEVICEHelena LaboratoriesK850542SURGICUTT - BLEEDING TIME DEVICEInternational Technidyne Corp.K830645BLEEDING TIME DEVICE DISPOSABLEAmerican DadeK761250SIMPLATEGeneral Diagnostics

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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