Geneva Laboratories, Inc.
Walker, MI, US
Geneva Laboratories, Inc. appears in FDA device records in Walker, MI. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Geneva Laboratories, Inc. between 1981 and 1988. The busiest year on record is 1988, with 4. The most recent is 1988, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1983 | 2 |
| 1984 | 2 |
| 1985 | 2 |
| 1986 | 2 |
| 1988 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K881217 | GENT-L-KARE STERILE URINARY LEG BAG | KNX | Substantially Equivalent | |
| K881218 | GENT-L-KARE CLEANSING ENEMA SET | FCE | Substantially Equivalent | |
| K881213 | GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER | KNX | Substantially Equivalent | |
| K881216 | GENT-L-KARE VAGINAL IRRIGATION SET | HED | Substantially Equivalent | |
| K861308 | ACCUPAC CUSTOM PACK KERLIX SQUARES | EFQ | Substantially Equivalent | |
| K861219 | ACCUPAC CUSTOM SKIN SCRUB KIT | Substantially Equivalent | ||
| K853265 | ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543 | Substantially Equivalent | ||
| K843206 | COOK COUNTY HOSPITAL DRESSING CHANGE SET | KDD | Substantially Equivalent | |
| K844255 | GENT-L-KARE STERILE I.V. START KIT | FPA | Substantially Equivalent | |
| K843090 | UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM | FPA | Substantially Equivalent | |
| K830725 | GENT-L-SPEC DISPOS. VAGINAL SPECULUM | HIB | Substantially Equivalent | |
| K822735 | SURE-COUNT DISPOSABLE NEEDLE COUNTER | MMK | Substantially Equivalent | |
| K802940 | SUPER-SPIKE TRANSFER SET | KSB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain