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IGM – Solution, Carnoy'S
Solution, Carnoy'S
FDA product code
IGM
· Class I (low risk) · 21 CFR 864.4010 ·
Pathology
3
510(k) clearances
0
PMA approvals
0
recalls
GMP exempt
exempt from GMP rules
Manufacturers
Marion Laboratories, Inc.
1
Volu Sol Medical Industries
1
E K Ind., Inc.
1
510(k) clearances
510(k)
Device
Applicant
Decision
K842737
Carnoy's Solution
IGM · Traditional
E K Ind., Inc.
09/07/1984
SE
K822126
Volu-Sol Carnoy Fluid
IGM · Traditional
Volu Sol Medical Industries
08/05/1982
SE
K790815
Culturette Brand Pva
IGM · Traditional
Marion Laboratories, Inc.
05/15/1979
SE