Atlas FDA

AQUAMATIC K-MODULE MODEL K-10

FDA 510(k) clearance K761337 · decided 1977-01-10

Clearance details

K-number
K761337
Device name
AQUAMATIC K-MODULE MODEL K-10
Applicant
Gorman Rupp Industries
Decision
Substantially Equivalent
Date received
1976-12-27
Decision date
1977-01-10
Days to decision
14 days
Clearance type
Traditional
Product code
JRR
Device class
1
Regulation number
862.2050
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
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
DADE CHILL TRAY (K822132)American Dade1982-08-05
HEMOGASTAT (K801148)Therapac, Inc.1980-06-09
KRYORACK/4 (K780757)Streck Laboratories, Inc.1978-06-06

Recalls involving this device

No recalls on record reference this clearance.