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FDA 510(k)

LIFE-TELL T.S.S.

K-Number: K932046 · 1994-08-29

ApplicantRaco Products Co.
Decision Date1994-08-29
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFE-TELL T.S.S. is the device name listed in this FDA 510(k) record. The listed applicant is Raco Products Co.. It received FDA 510(k) clearance on 1994-08-29 under 510(k) number K932046. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFE-TELL T.S.S.?

LIFE-TELL T.S.S. is a medical device that received FDA 510(k) clearance on 1994-08-29. The listed applicant is Raco Products Co.. The 510(k) number is K932046.

When did LIFE-TELL T.S.S. receive FDA 510(k) clearance?

LIFE-TELL T.S.S. received FDA 510(k) clearance on 1994-08-29, under 510(k) number K932046.

Who is the listed applicant for LIFE-TELL T.S.S.?

The FDA 510(k) record lists Raco Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFE-TELL T.S.S.?

The FDA product code for LIFE-TELL T.S.S. is DXH. This falls under the Hematology category.

Other records listing Raco Products Co. 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.

K923493LIFE-TEL T.R.S.K922563LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR)K920990LIFE-TEL L.B.E.(LIFE-PAK 5/10 BATTERY ELIMINATOR)

Related Devices (Code: DXH)

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.

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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