Intiwash Manual Microplate Washer

FDA 510(k) K850371 · Inti Corp.

Substantially Equivalent

510(k) numberK850371

Submission

Device name
Intiwash Manual Microplate Washer
Applicant
Inti Corp.
San Rafael, CA, US
Received
January 31, 1985
Decision date
March 11, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JTC – Device, Microtiter Diluting/Dispensing
Device class
Class I (low risk)
Regulation
21 CFR 866.2500
Specialty
Microbiology

Other 510(k)s with product code JTC

510(k)DeviceApplicantDecision
K924907Filtermate Universal HarvesterJTC · Traditional Packard Instrument Co., Inc.12/01/1992SE
K901808Micromate 196 Model A961960JTC · Traditional Packard Instrument Co., Inc.06/20/1990SE
K894645Immulon 1,2,3,AND 4 Dividastrips TMJTC · Traditional Dynatech Laboratories, Inc.10/17/1989SE
K892369Multi-Probe Head PlusJTC · Traditional Hamilton Co.06/02/1989SE
K891768Genetic Systems Microplate WasherJTC · Traditional Genetic Systems Corp.05/01/1989SE
K891766Genetic Systems Microplate Strip WasherJTC · Traditional Genetic Systems Corp.05/01/1989SE
K891765Genetic Systems Pipettor/DilutorJTC · Traditional Genetic Systems Corp.05/01/1989SE
K884695Washer 500 Microelisa SystemJTC · Traditional Organon Teknika Corp.12/13/1988SE
K884125Bio-Tek Automated Microplate Washer Model EL403JTC · Traditional Bio-Tek Instruments, Inc.12/02/1988SE
K874598Dynatech MR 250 Manual Microelisa ReaderJTC · Traditional Dynatech Laboratories, Inc.11/20/1987SE

Questions and answers

When was Intiwash Manual Microplate Washer cleared by the FDA?

Intiwash Manual Microplate Washer (K850371) received a 510(k) decision of Substantially Equivalent on March 11, 1985, 39 days after the submission was received.

What is the product code of K850371?

The FDA product code is JTC – Device, Microtiter Diluting/Dispensing, a Class I (low risk) device regulated under 21 CFR 866.2500.