Who is the manufacturer of CHROM Z-PROTEIN C, CAT. NO. 5243?

Helena Laboratories filed the 510(k) submission for CHROM Z-PROTEIN C, CAT. NO. 5243 (K952666).

What is the FDA product code for CHROM Z-PROTEIN C, CAT. NO. 5243?

GGP. It is classified under 21 CFR 864.7290 as a Class 2 device in the Hematology panel.

What is the regulatory pathway for CHROM Z-PROTEIN C, CAT. NO. 5243?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CHROM Z-PROTEIN C, CAT. NO. 5243?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CHROM Z-PROTEIN C, CAT. NO. 5243

K952666 · Helena Laboratories · GGP · Jan 30, 1996 · Hematology

Device Facts

Record ID	K952666
Device Name	CHROM Z-PROTEIN C, CAT. NO. 5243
Applicant	Helena Laboratories
Product Code	GGP · Hematology
Decision Date	Jan 30, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 864.7290
Device Class	Class 2

CHROM Z-PROTEIN C, CAT. NO. 5243

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