Company ยท US
Geneva Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1988. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FPA | Set, Administration, Intravascular | 2 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 2 |
| EFQ | Gauze/Sponge, Internal | 1 |
| FCE | Enema Kit | 1 |
| HED | Douche Apparatus, Vaginal, Therapeutic | 1 |
| HIB | Speculum, Vaginal, Nonmetal | 1 |
| KDD | Kit, Surgical Instrument, Disposable | 1 |
| KSB | Set, Transfer (Blood/Plasma) | 1 |
| MMK | Container, Sharps | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 29, 1988 | K881217 | GENT-L-KARE STERILE URINARY LEG BAG Geneva Laboratories, Inc. | KNX |
| Jul 28, 1988 | K881218 | GENT-L-KARE CLEANSING ENEMA SET Geneva Laboratories, Inc. | FCE |
| Jul 28, 1988 | K881213 | GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER Geneva Laboratories, Inc. | KNX |
| Jun 7, 1988 | K881216 | GENT-L-KARE VAGINAL IRRIGATION SET Geneva Laboratories, Inc. | HED |
| May 2, 1986 | K861308 | ACCUPAC CUSTOM PACK KERLIX SQUARES Geneva Laboratories, Inc. | EFQ |
| Apr 15, 1986 | K861219 | ACCUPAC CUSTOM SKIN SCRUB KIT Geneva Laboratories, Inc. | |
| Aug 26, 1985 | K853265 | ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543 Geneva Laboratories, Inc. | |
| May 24, 1985 | K843206 | COOK COUNTY HOSPITAL DRESSING CHANGE SET Geneva Laboratories, Inc. | KDD |
| Dec 19, 1984 | K844255 | GENT-L-KARE STERILE I.V. START KIT Geneva Laboratories, Inc. | FPA |
| Dec 4, 1984 | K843090 | UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM Geneva Laboratories, Inc. | FPA |
| Apr 27, 1983 | K830725 | GENT-L-SPEC DISPOS. VAGINAL SPECULUM Geneva Laboratories, Inc. | HIB |
| Mar 9, 1983 | K822735 | SURE-COUNT DISPOSABLE NEEDLE COUNTER Geneva Laboratories, Inc. | MMK |
| Jan 15, 1981 | K802940 | SUPER-SPIKE TRANSFER SET Geneva Laboratories, Inc. | KSB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||