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510(k) K892522

SR30/SR50/SR60 AUTO SEDIMENT RATE SYSTEM, MODIFIED by Gespac, Inc. — Product Code GKB

K892522 is an FDA 510(k) premarket notification submitted by Gespac, Inc. for the device "SR30/SR50/SR60 AUTO SEDIMENT RATE SYSTEM, MODIFIED". The FDA issued a decision of Substantially Equivalent on May 24, 1989. The device falls under product code GKB (Device, Automated Sedimentation Rate), a Class I device regulated under 21 CFR 864.5800. Gespac, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1989
Date Received
April 11, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Automated Sedimentation Rate
Device Class
Class I
Regulation Number
864.5800
Review Panel
HE
Submission Type

Other clearances by Gespac, Inc.

  • K890503 — SR30/SR50/SR60 AUTOMATED SEDIMENTATION RATE (February 10, 1989)

Other clearances for product code GKB

  • K890503 — SR30/SR50/SR60 AUTOMATED SEDIMENTATION RATE (February 10, 1989)

FDA data resources