Versablot

FDA 510(k) K884258 · American Bionetics, Inc.

Substantially Equivalent

510(k) numberK884258

Submission

Device name
Versablot
Applicant
American Bionetics, Inc.
Hayward, CA, US
Received
October 11, 1988
Decision date
December 14, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KPA – Slide Stainer, Automated
Device class
Class I (low risk)
Regulation
21 CFR 864.3800
Specialty
Pathology

Other 510(k)s with product code KPA

510(k)DeviceApplicantDecision
K933996ProfiblotKPA · Traditional Tecan U.S., Ltd.01/28/1994SE
K881592Wescor Model 7300 Aerospray Gram StainerKPA · Traditional Wescor, Inc.05/13/1988SE
K880745LX-100 Slide StainerKPA · Traditional Innovative Medical Systems, Inc.04/27/1988SE
K874887Wesblot ProcessorKPA · Traditional American Bionetics, Inc.03/24/1988SE
K874897Sakura DRS-60 Automatic Slide StainerKPA · Traditional Sakura Finetek U.S.A., Inc.01/05/1988SE
K872916Histomatic Slide Stainer, Code-On VersionKPA · Traditional Fisher Scientific Co., LLC09/14/1987SE
K853210MST-1050-II X-Ray UnitKPA · Traditional Radiological Engineering, Inc.10/10/1985SE
K850333Pump Tube Sets for Hema-Tek I & II Slide StainersKPA · Traditional Shaban Mfg. Co.02/27/1985SE
K850157Cannulas for Hema-Tek I & KK Slide StainersKPA · Traditional Shaban Mfg. Co.02/27/1985SE
K842077Midas II Automatic StainerKPA · Traditional Innovative Medical Systems, Inc.07/27/1984SE

More from Innovative Medical Systems, Inc.

510(k)DeviceDecision
K881379Wesblot Rnp-Sm TestLKP · Traditional 05/16/1988SE
K874887Wesblot ProcessorKPA · Traditional 03/24/1988SE

Questions and answers

When was Versablot cleared by the FDA?

Versablot (K884258) received a 510(k) decision of Substantially Equivalent on December 14, 1988, 64 days after the submission was received.

What is the product code of K884258?

The FDA product code is KPA – Slide Stainer, Automated, a Class I (low risk) device regulated under 21 CFR 864.3800.