Atlas FDA

LABILE REMOVING HEMOLYZING REAGENT

FDA 510(k) clearance K830804 · decided 1983-05-04

Clearance details

K-number
K830804
Device name
LABILE REMOVING HEMOLYZING REAGENT
Applicant
Corning Medical & Scientific
Decision
Substantially Equivalent
Date received
1983-03-14
Decision date
1983-05-04
Days to decision
51 days
Clearance type
Traditional
Product code
JBD
Device class
2
Regulation number
864.7440
Medical specialty
Hematology
Advisory committee
Hematology
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
MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM (K053571)Interlab S.R.L.2006-06-30
INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM (K032862)Interlab S.R.L.2004-02-03
ACID HEMOGLOBIN KIT (K992199)Helena Laboratories1999-09-21
HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) (K991362)Morax1999-06-21
SPIFE ALKALINE HEMOGLOBIN (K982426)Helena Laboratories1998-12-17
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) (K931503)Helena Laboratories1993-08-16
REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 (K931465)Helena Laboratories1993-07-06
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) (K901143)Helena Laboratories1990-05-23
GELMAN GLYCO-PHORE BUFFER (K820518)Gelman Sciences, Inc.1982-04-09
CELLULOSE ACETATE-CITRATE AGAR HEMOGLO (K813395)Helena Laboratories1981-12-31
HEMOGLOBIN ELECTROPHORESIS CONTROL (K810919)Isolab, Inc.1981-04-23
AUTOPHOR 128 (K810047)Gelman Sciences, Inc.1981-02-05

Recalls involving this device

No recalls on record reference this clearance.