Atlas FDA

KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP

FDA 510(k) clearance K771925 · decided 1977-11-02

Clearance details

K-number
K771925
Device name
KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP
Applicant
Harleco
Decision
Substantially Equivalent
Date received
1977-10-14
Decision date
1977-11-02
Days to decision
19 days
Clearance type
Traditional
Product code
KES
Device class
1
Regulation number
864.3010
Medical specialty
Pathology
Advisory committee
Pathology
Location
Mchenry, IL, 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
SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPER (K882881)Sakura Finetek U.S.A., Inc.1988-07-28
MICROSCOPE COVER GLASSES (K872874)Abco Dealers, Inc.1987-08-10

Recalls involving this device

No recalls on record reference this clearance.