Atlas FDA

RID PLATE READER

FDA 510(k) clearance K881174 · decided 1988-06-08

Clearance details

K-number
K881174
Device name
RID PLATE READER
Applicant
The Binding Site, Ltd.
Decision
Substantially Equivalent
Date received
1988-03-18
Decision date
1988-06-08
Days to decision
82 days
Clearance type
Traditional
Product code
JZQ
Device class
1
Regulation number
866.4800
Medical specialty
Immunology
Advisory committee
Immunology
Location
Los Angeles, CA, 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
IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS (K881675)Dynatech Laboratories, Inc.1988-04-21
REVOLUTION RADIAL IMMUNODIFFUSION PLATE (K831811)Calbiochem-Behring Corp.1983-07-28
OUCHTERLONY AGAR PLATES (K792699)Meridian Diagnostics, Inc.1980-01-24
HELENA QUIPLATE SYSTEM (K790646)Helena Laboratories1979-05-23
IMMUNOPLATE III RADIO IMMUNODIFFUSION (K770548)Hyland Therapeutic Div., Travenol Laboratories1977-04-15
ACCRAASSAY RID KITS (K761311)Miles Laboratories, Inc.1976-12-30

Recalls involving this device

No recalls on record reference this clearance.