Picric Acid Saturated Solution

FDA 510(k) K842922 · E K Ind., Inc.

Substantially Equivalent

510(k) numberK842922

Submission

Device name
Picric Acid Saturated Solution
Applicant
E K Ind., Inc.
Mchenry, IL, US
Received
July 25, 1984
Decision date
September 7, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LDW – Fixative, Acid Containing
Device class
Class I (low risk)
Regulation
21 CFR 864.4010
Specialty
Pathology

Other 510(k)s with product code LDW

510(k)DeviceApplicantDecision
K883062Ats Schaudinn's Fixative W/Acetic AcidLDW · Traditional Alpha-Tec Systems, Inc.08/04/1988SE
K842923Picric Acid 1% W/VLDW · Traditional E K Ind., Inc.09/11/1984SE
K831058Saf FixativeLDW · Traditional American Micro Scan06/08/1983SE

More from American Micro Scan

510(k)DeviceDecision
K842931Drabkin ReagentKAG · Traditional 09/21/1984SE
K842938Acetic Acid 1% V/VGGK · Traditional 09/14/1984SE
K842937Acetic Acid 2% V/VGGK · Traditional 09/12/1984SE
K842936Acetic Acid, 3% V/VGGK · Traditional 09/12/1984SE
K842935Acetic Acid, 5% V/VGGK · Traditional 09/12/1984SE
K842934Decolorizing Fluic, Acid-Alcohol 3%PPM · Traditional 09/12/1984SE
K842933Carbol-Fuchsin, Ziehl-NeedsenICL · Traditional 09/11/1984SE
K842930Gomori's Trichrome StainLED · Traditional 09/11/1984SE
K842928Jenner Blood StainKJX · Traditional 09/11/1984SE
K842927Light Green SF 1%HYS · Traditional 09/11/1984SE

Questions and answers

When was Picric Acid Saturated Solution cleared by the FDA?

Picric Acid Saturated Solution (K842922) received a 510(k) decision of Substantially Equivalent on September 7, 1984, 44 days after the submission was received.

What is the product code of K842922?

The FDA product code is LDW – Fixative, Acid Containing, a Class I (low risk) device regulated under 21 CFR 864.4010.