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FDA 510(k)

A,FSC LYOPHILIZED HEMO CONTROL

K-Number: K800855 · 1980-04-29

ApplicantHelena Laboratories
Decision Date1980-04-29
Product CodeJBD
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

A,FSC LYOPHILIZED HEMO CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1980-04-29 under 510(k) number K800855. The device is classified under product code JBD. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A,FSC LYOPHILIZED HEMO CONTROL?

A,FSC LYOPHILIZED HEMO CONTROL is a medical device that received FDA 510(k) clearance on 1980-04-29. The listed applicant is Helena Laboratories. The 510(k) number is K800855.

When did A,FSC LYOPHILIZED HEMO CONTROL receive FDA 510(k) clearance?

A,FSC LYOPHILIZED HEMO CONTROL received FDA 510(k) clearance on 1980-04-29, under 510(k) number K800855.

Who is the listed applicant for A,FSC LYOPHILIZED HEMO CONTROL?

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

What is the FDA product code for A,FSC LYOPHILIZED HEMO CONTROL?

The FDA product code for A,FSC LYOPHILIZED HEMO CONTROL is JBD.

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Other records listing Helena Laboratories 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.

K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLK100103SPECIALTY ASSAYED CONTROL-2K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK050053HEMORAM/AGGRAM ANALYZER

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Related Devices (Code: JBD)

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.

K053571MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEMInterlab S.R.L.K032862INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEMInterlab S.R.L.K992199ACID HEMOGLOBIN KITHelena LaboratoriesK991362HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)MoraxK982426SPIFE ALKALINE HEMOGLOBINHelena LaboratoriesK931503REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)Helena Laboratories

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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