SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)

Single (specified) Analyte Controls (assayed And Unassayed)

QUIDEL CORP.

The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Serum Hcg Control Set (negative, Low Positive And High Positive).

Pre-market Notification Details

• Device ID: K974108
• 510k Number: K974108
• Device Name: SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)
• Classification: Single (specified) Analyte Controls (assayed And Unassayed)
• Applicant: QUIDEL CORP. 10165 MCKELLAR CT. San Diego, CA 92121
• Contact: Edward J Mcmullen
• Correspondent: Edward J Mcmullen; QUIDEL CORP. 10165 MCKELLAR CT. San Diego, CA 92121
• Product Code: JJX
• CFR Regulation Number: 862.1660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-10-31
• Decision Date: 1997-11-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30014613002819	K974108	000