Device Atlas

A O Histostat Embedding CTR #8030,32,34

Q: What is the product code of K821831?

The FDA product code is IDS – Melting Pot, Paraffin, a Class I (low risk) device regulated under 21 CFR 864.3010.

FDA 510(k) K821831 · Warner-Lambert Co.

Substantially Equivalent

510(k) numberK821831

Submission

Device name: A O Histostat Embedding CTR #8030,32,34
Applicant: Warner-Lambert Co.
Mchenry, IL, US
Received: June 22, 1982
Decision date: July 13, 1982
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: IDS – Melting Pot, Paraffin
Device class: Class I (low risk)
Regulation: 21 CFR 864.3010
Specialty: Pathology

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Questions and answers

When was A O Histostat Embedding CTR #8030,32,34 cleared by the FDA?

A O Histostat Embedding CTR #8030,32,34 (K821831) received a 510(k) decision of Substantially Equivalent on July 13, 1982, 21 days after the submission was received.

What is the product code of K821831?

The FDA product code is IDS – Melting Pot, Paraffin, a Class I (low risk) device regulated under 21 CFR 864.3010.