510(k) K855203
- Device
- GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD
- Applicant
- MILES LABORATORIES, INC.
- 510(k) number
- K855203
- Product code
- FMK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-02-11
- Date received
- 1985-12-26
- Regulation
- 878.4800
- Classification name
- Lancet, Blood
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN ENGELMANN
- Address
- 1127 Myrtle St. P.O. Box 40 Elkhart IN US 46514 46514
FDA Registration Numbers#
- 3002807408
- 3009498536
- 3014383302
- 1000113657
- 2029275
- 3013226
- 3008789114
- 3011369203
- 3031233007
- 3014150341
- 3008061617
- 3011088743
- 3007499349
- 3026211706
- 3030186688
- 3015209536
- 3005862821
- 3009498548
- 9615507
- 3010834934
- 1832816
- 3026940910
- 9617475
- 2954323
- 3009109626
- 3030691709
- 3012598266
- 3010194621
- 3009171251
- 3013019728
- 3007441619
- 3012034017
- 3038184658
- 1721183
- 8031690
- 3007594734
- 3013188547
- 8021764
- 3021314645
- 3043534762
- 3011845225
- 3021286079
- 1217183
- 3011526299
- 3021169869
- 3010515547
- 3013496867
- 3022147580
- 3021244152
- 3014649053
- 3030896267
- 3010419931
- 3006446479
- 3015142721
- 2243072
- 3006210673
- 3017247483
- 3003917514
- 3006899020
- 3002721930
- 3002773714
- 3003902721
- 3004143450
- 3016096098
- 3004911384
- 1722458
- 3007507465
- 3043226252
- 3005273623
- 3003965134
- 3003449582
- 3002807315
- 3038356900
- 3024273968
- 3007134734
- 3008936260
- 3004748528
- 3013143994
- 3005280205
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FMK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261045 | Verifine Safety Lancets | Promisemed Hangzhou Meditech Co., Ltd. | 2026-05-01 |
| K260191 | Safety lancet (XXXVII) | Tianjin Huahong Technology Co., Ltd. | 2026-03-31 |
| K253605 | Safety Heel Lancet | Ningbo Medsun Medical Co., Ltd. | 2026-02-20 |
| K252490 | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) | Tianjin Huahong Technology Co., Ltd. | 2026-02-12 |
| K251694 | safety lancet | Tianjin Huahong Technology Co., Ltd. | 2025-06-26 |
| K244036 | Heel Incision Safety Lancet (SteriHeel 2) | SteriLance Medical (Suzhou), Inc. | 2025-02-26 |
| K243533 | Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus | Hlb Co., Ltd. Healthcare | 2025-01-13 |
| K242680 | LetsGetChecked Impress | Privapath Diagnostics Ltd (Dba Letsgetchecked) | 2025-01-13 |
| K242664 | gentleheel® Adult Incision Device | Gri-Alleset, Inc. | 2024-11-05 |
| K242627 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | 2024-10-30 |
| K242316 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | 2024-08-28 |
| K241848 | MedtFine Safety Lancet | Ningbo Caremed Medical Products Co., Ltd. | 2024-08-20 |
| K241750 | Medifun Safety Lancet ( MSL1 series) | Medifun Corporation | 2024-08-15 |
| K241627 | Safety Lancet (XXXV) | Tianjin Huahong Technology Co., Ltd. | 2024-06-20 |
| K240806 | Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) | Tianjin Huahong Technology Co., Ltd. | 2024-05-21 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases