Product code JSX— Microbiology

FDA has cleared 16 devices under product code JSX between 1978 and 1996, filed by 16 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19961 clearance
• 19921 clearance
• 19911 clearance
• 19882 clearances
• 19871 clearance
• 19853 clearances
• 19833 clearances
• 19812 clearances
• 19791 clearance
• 19781 clearance

• Windsor Laboratories, Inc.1 clearance
• Remel Co.1 clearance
• Pro-Lab, Inc.1 clearance
• Pharmacia, Inc.1 clearance
• Oxoid U.S.A., Inc.1 clearance
• Miles Laboratories, Inc.1 clearance
• Micro-Bio-Logics1 clearance
• Medtex Laboratories, Inc.1 clearance
• Kev Connecticut Diagnostics, Inc.1 clearance
• Innovative Diagnostic Systems, Inc.1 clearance

• K960759 — GONOPOX TEST KITMedtex Laboratories, Inc.·1996-09-18
• K923566 — NIZYME TEST KITRemel Co.·1992-11-02
• K913456 — VISI-NEISSERIAKev Connecticut Diagnostics, Inc.·1991-10-11
• K880511 — XACT NEISSERIAAustin Biological Laboratories·1988-08-25
• K881501 — MODIFIED IDS RAPID NH SYSTEMInnovative Diagnostic Systems, Inc.·1988-05-18
• K870117 — NEISSERIA/BRANHAMELLA DIFFERENTIAL TESTPro-Lab, Inc.·1987-03-20
• K853544 — QUAD FERM +Analytical Products, Inc.·1985-09-05
• K852998 — NEISSERIA - KWIK PLUSMicro-Bio-Logics·1985-07-23
• K852582 — GONI-KITCulture Kits, Inc.·1985-07-12
• K833307 — PHADEBACK G.C. POSITIVE CONTROLSPharmacia, Inc.·1983-12-27
• K833180 — GONOCHEK-IIE-Y Laboratories, Inc.·1983-11-14
• K830364 — NEISSERIA IDENTIFICATION DISCSOxoid U.S.A., Inc.·1983-03-08
• K812048 — IDS RAPIDS NH SYSTEMSCarr-Scarborough Microbiologicals, Inc.·1981-08-18
• K811412 — NEISSERIA-KWIKWindsor Laboratories, Inc.·1981-06-16
• K782013 — GONO-CELLAbbott Laboratories·1979-04-23
• K781108 — MICROCULT-GC CULTURE TESTMiles Laboratories, Inc.·1978-08-31