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FDA 510(k)

AUTO-LANCET

K-Number: K833344 · 1983-11-07

ApplicantPalco Laboratories, Inc.
Decision Date1983-11-07
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AUTO-LANCET is the device name listed in this FDA 510(k) record. The listed applicant is Palco Laboratories, Inc.. It received FDA 510(k) clearance on 1983-11-07 under 510(k) number K833344. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO-LANCET?

AUTO-LANCET is a medical device that received FDA 510(k) clearance on 1983-11-07. The listed applicant is Palco Laboratories, Inc.. The 510(k) number is K833344.

When did AUTO-LANCET receive FDA 510(k) clearance?

AUTO-LANCET received FDA 510(k) clearance on 1983-11-07, under 510(k) number K833344.

Who is the listed applicant for AUTO-LANCET?

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

What is the FDA product code for AUTO-LANCET?

The FDA product code for AUTO-LANCET is FMK.

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Other records listing Palco 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.

K942810PALCO LABS COLD POUCHK943842PULSE OXIMETER MODEL 305K920066PALCO LABS MODEL 340 PULSE OXIMETERK913694PALCO LABS LOADMATICK911191PALCO LABS MODEL 300 OXYGEN/PULSE MONITORK904988PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR

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Related Devices (Code: FMK)

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.

K262526Safety lancet (XL)Tianjin Huahong Technology Co., Ltd.K261045Verifine Safety LancetsPromisemed Hangzhou Meditech Co., Ltd.K260191Safety lancet (XXXVII)Tianjin Huahong Technology Co., Ltd.K253605Safety Heel LancetNingbo Medsun Medical Co., Ltd.K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd.K251694safety lancetTianjin Huahong Technology Co., Ltd.

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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