Atlas FDA

HEMATOXYLIN STAIN SOLUTION

FDA 510(k) clearance K822352 · decided 1982-08-16

Clearance details

K-number
K822352
Device name
HEMATOXYLIN STAIN SOLUTION
Applicant
Fisher Scientific Co., LLC
Decision
Substantially Equivalent
Date received
1982-08-06
Decision date
1982-08-16
Days to decision
10 days
Clearance type
Traditional
Product code
HYJ
Device class
1
Regulation number
864.1850
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
ANATECH HEMATOXYLIN-NORMAL STRENGTH (K872499)Anatech, Ltd.1987-07-09
ANATECH HEMATOXYLIN-EXTRA STRENGTH (K872500)Anatech, Ltd.1987-07-09
DELAFIELD HEMATOXYLIN STAIN (K842740)E K Ind., Inc.1984-08-17
GILL HEMATOXYLIN STAIN (K842741)E K Ind., Inc.1984-08-15
HEMATOXYLIN GILL FORMULATION IX#56016 (K831090)Accra Laboratories, Inc.1983-06-08
HEMATOXYLIN I (K821533)Volu Sol Medical Industries1982-06-10
HEMATOXYLIN II (K821540)Volu Sol Medical Industries1982-06-10
HEMATOXYLIN III (K821541)Volu Sol Medical Industries1982-06-10
HEMATOXYLIN STAIN (K821320)Sigma Chemical Co.1982-06-02
HEMATOXYLIN SOLUTION (K821062)Sigma Chemical Co.1982-04-29
HEMATOXYLIN (K811802)Richard-Allan Medical Ind., Inc.1981-07-28
GILL'S HEMATOXYLIN #1 (K810758)Surgipath1981-04-14

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
FLUORESCENT GONORRHEA TEST-HEATED (FGT-H) (P770001)Fisher Scientific Co., LLC1979-07-18