Cmv-Cube(Tm)
FDA 510(k) K884842 · Difco Laboratories, Inc.
510(k) numberK884842
Submission
- Device name
- Cmv-Cube(Tm)
- Applicant
- Difco Laboratories, Inc.
Detroit, MI, US - Received
- November 21, 1988
- Decision date
- April 11, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LFZ – Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3175
- Specialty
- Microbiology
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| K953129 | Esp Culture System - MycoMDB · Traditional | 12/26/1995SE |
| K950706 | Dryslide CoagulaseJTL · Traditional | 05/16/1995SE |
| K944275 | Dispens-O-Disc Piperacillin 100 Mcg./Tazobactam 10 Mcg.JTN · Traditional | 12/19/1994SE |
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Questions and answers
When was Cmv-Cube(Tm) cleared by the FDA?
Cmv-Cube(Tm) (K884842) received a 510(k) decision of Substantially Equivalent on April 11, 1989, 141 days after the submission was received.
What is the product code of K884842?
The FDA product code is LFZ – Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.