Atlas FDA

CENTRICON MICRO-CONCENTRATOR

FDA 510(k) clearance K833919 · decided 1984-01-30

Clearance details

K-number
K833919
Device name
CENTRICON MICRO-CONCENTRATOR
Applicant
Amicon, Inc.
Decision
Substantially Equivalent
Date received
1983-11-14
Decision date
1984-01-30
Days to decision
77 days
Clearance type
Traditional
Product code
JJH
Device class
1
Regulation number
862.2310
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Walker, MI, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ESENSOR RESPIRATORY VIRAL PANEL (K113731)Clinical Micro Sensors, Inc.2012-09-10
VIVASPIN 4 10,000 MW (K960298)Vivascience, Inc.1996-03-19
VIVAPORE 10 (K943965)Vivascience, Inc.1995-04-11
VIVAPORE 2 (K943966)Vivascience, Inc.1995-04-11
ULTRAFREE-CL (K941326)Millipore Corp.1994-05-27
NANOSEP N10 (K935496)Intersep , Ltd.1994-04-26
CENTRICON -50 CONCENTRATOR (K930168)Amicon, Inc.1993-08-05
CENTRICON CONCENTRATOR (K893733)Amicon, Inc.1989-07-20
CENTRICELL(TM) (K871290)Polysciences, Inc.1987-08-05
CENTRIPREP CONCENTRATOR (K870690)Amicon, Inc.1987-03-19
DUPONT PREP FOUR-SOLVENT RETROFIT KIT (K851393)E.I. Dupont DE Nemours & Co., Inc.1985-07-12
MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG (K801772)Radiation Technology, Inc.1980-08-20

Recalls involving this device

No recalls on record reference this clearance.