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).
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30014613002819 | K974108 | 000 |