Cellmatic Chlamydia Culture CONFIRM-DIFCO-1000
FDA 510(k) K860292 · Difco Laboratories, Inc.
510(k) numberK860292
Submission
- Device name
- Cellmatic Chlamydia Culture CONFIRM-DIFCO-1000
- Applicant
- Difco Laboratories, Inc.
Ann Arbor, MI, US - Received
- January 28, 1986
- Decision date
- February 5, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KIR – Cells, Animal And Human, Cultured
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.2280
- Specialty
- Hematology
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| K944275 | Dispens-O-Disc Piperacillin 100 Mcg./Tazobactam 10 Mcg.JTN · Traditional | 12/19/1994SE |
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Questions and answers
When was Cellmatic Chlamydia Culture CONFIRM-DIFCO-1000 cleared by the FDA?
Cellmatic Chlamydia Culture CONFIRM-DIFCO-1000 (K860292) received a 510(k) decision of Substantially Equivalent on February 5, 1986, 8 days after the submission was received.
What is the product code of K860292?
The FDA product code is KIR – Cells, Animal And Human, Cultured, a Class I (low risk) device regulated under 21 CFR 864.2280.