Product code JJH— Clinical Chemistry

FDA has cleared 15 devices under product code JJH between 1976 and 2012, filed by 8 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.

• 20121 clearance
• 19961 clearance
• 19952 clearances
• 19942 clearances
• 19931 clearance
• 19891 clearance
• 19872 clearances
• 19851 clearance
• 19841 clearance
• 19801 clearance
• 19771 clearance
• 19761 clearance

• Amicon, Inc.6 clearances
• Vivascience, Inc.3 clearances
• Radiation Technology, Inc.1 clearance
• Polysciences, Inc.1 clearance
• Millipore Corp.1 clearance
• Intersep , Ltd.1 clearance
• E.I. Dupont DE Nemours & Co., Inc.1 clearance
• Clinical Micro Sensors, Inc.1 clearance

• K113731 — ESENSOR RESPIRATORY VIRAL PANELClinical Micro Sensors, Inc.·2012-09-10
• K960298 — VIVASPIN 4 10,000 MWVivascience, Inc.·1996-03-19
• K943965 — VIVAPORE 10Vivascience, Inc.·1995-04-11
• K943966 — VIVAPORE 2Vivascience, Inc.·1995-04-11
• K941326 — ULTRAFREE-CLMillipore Corp.·1994-05-27
• K935496 — NANOSEP N10Intersep , Ltd.·1994-04-26
• K930168 — CENTRICON -50 CONCENTRATORAmicon, Inc.·1993-08-05
• K893733 — CENTRICON CONCENTRATORAmicon, Inc.·1989-07-20
• K871290 — CENTRICELL(TM)Polysciences, Inc.·1987-08-05
• K870690 — CENTRIPREP CONCENTRATORAmicon, Inc.·1987-03-19
• K851393 — DUPONT PREP FOUR-SOLVENT RETROFIT KITE.I. Dupont DE Nemours & Co., Inc.·1985-07-12
• K833919 — CENTRICON MICRO-CONCENTRATORAmicon, Inc.·1984-01-30
• K801772 — MICROBIOLOGY CULTURE MEDIA-MACCONKEY AGRadiation Technology, Inc.·1980-08-20
• K770398 — MINICONAmicon, Inc.·1977-04-06
• K760592 — MINICON CONCENTRATORAmicon, Inc.·1976-11-23