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FDA 510(k)

REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170

K-Number: K881852 · 1988-07-08

ApplicantHelena Laboratories
Decision Date1988-07-08
Product CodeJJN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1988-07-08 under 510(k) number K881852. The device is classified under product code JJN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170?

REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170 is a medical device that received FDA 510(k) clearance on 1988-07-08. The listed applicant is Helena Laboratories. The 510(k) number is K881852.

When did REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170 receive FDA 510(k) clearance?

REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170 received FDA 510(k) clearance on 1988-07-08, under 510(k) number K881852.

Who is the listed applicant for REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170?

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 REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170?

The FDA product code for REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170 is JJN.

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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: JJN)

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.

K924021POWER SUPPLYThe Binding Site, Ltd.K924020ELECTROPHORESIS TANKThe Binding Site, Ltd.K882344ELECTR-TRANSBLOTTERThe W.E.P. Co.K882163HELENA REP GEL PROCESSORHelena LaboratoriesK873352RAPID ELECTROPHORESIS SYSTEM (REP)Helena LaboratoriesK864436STAVIP 3000Roseburg SA

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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