510(k) K854615

MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES by Serono Diagnostics, Inc. — Product Code LKI

K854615 is an FDA 510(k) premarket notification submitted by Serono Diagnostics, Inc. for the device "MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES". The FDA issued a decision of Substantially Equivalent on January 28, 1986. The device falls under product code LKI (Antisera, Fluorescent, Chlamydia Spp.), a Class I device regulated under 21 CFR 866.3120. Serono Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 28, 1986
Date Received: November 18, 1985
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Antisera, Fluorescent, Chlamydia Spp.
Device Class: Class I
Regulation Number: 866.3120
Review Panel: MI
Submission Type

Other clearances by Serono Diagnostics, Inc.

K953598 — SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS (March 11, 1996)
K942051 — SR1 DHEA-S ENZYME IMMUNOASSAY (July 13, 1994)
K883085 — T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS (September 9, 1988)
K882340 — LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA (August 8, 1988)
K880388 — T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE (March 3, 1988)
K874866 — T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE (February 11, 1988)
K873431 — PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH (October 20, 1987)
K873186 — LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA (September 29, 1987)
K873400 — PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA (September 25, 1987)
K872862 — PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS (September 18, 1987)

510(k) K854615

Clearance Details

Device Classification

Other clearances by Serono Diagnostics, Inc.

Other clearances for product code LKI

FDA data resources