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FDA 510(k)

MID-LEVEL IGG KIT CAT. NO. 9315

K-Number: K891299 · 1989-03-22

ApplicantHelena Laboratories
Decision Date1989-03-22
Product CodeDAQ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MID-LEVEL IGG KIT CAT. NO. 9315 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1989-03-22 under 510(k) number K891299. The device is classified under product code DAQ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MID-LEVEL IGG KIT CAT. NO. 9315?

MID-LEVEL IGG KIT CAT. NO. 9315 is a medical device that received FDA 510(k) clearance on 1989-03-22. The listed applicant is Helena Laboratories. The 510(k) number is K891299.

When did MID-LEVEL IGG KIT CAT. NO. 9315 receive FDA 510(k) clearance?

MID-LEVEL IGG KIT CAT. NO. 9315 received FDA 510(k) clearance on 1989-03-22, under 510(k) number K891299.

Who is the listed applicant for MID-LEVEL IGG KIT CAT. NO. 9315?

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 MID-LEVEL IGG KIT CAT. NO. 9315?

The FDA product code for MID-LEVEL IGG KIT CAT. NO. 9315 is DAQ.

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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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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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