The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine Calibrators, Lzi Methamphetamine Controls.
Device ID | K113661 |
510k Number | K113661 |
Device Name: | LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS |
Classification | Gas Chromatography, Methamphetamine |
Applicant | Lin-Zhi International, Inc. 670 ALMANOR AVE Sunnyvale, CA 94085 |
Contact | Bernice Lin |
Correspondent | Bernice Lin Lin-Zhi International, Inc. 670 ALMANOR AVE Sunnyvale, CA 94085 |
Product Code | LAF |
Subsequent Product Code | DLJ |
Subsequent Product Code | LAS |
CFR Regulation Number | 862.3610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-12-13 |
Decision Date | 2012-01-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B07603580 | K113661 | 000 |
00811727018311 | K113661 | 000 |
00811727018328 | K113661 | 000 |
00811727018335 | K113661 | 000 |
00811727018342 | K113661 | 000 |
00811727018359 | K113661 | 000 |
00811727018366 | K113661 | 000 |
00811727018373 | K113661 | 000 |
B07603500 | K113661 | 000 |
B07603510 | K113661 | 000 |
B07603520 | K113661 | 000 |
B07603530 | K113661 | 000 |
B07603540 | K113661 | 000 |
B07603550 | K113661 | 000 |
B07603570 | K113661 | 000 |
00811727018304 | K113661 | 000 |